NRAC Issue #1701 ADDENDUM September 30, 2008 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ ****CORRECTION**** In Recall Issue #1700, September 23, 2008 Recall # Z-1659-2008, page 1 of Part B, under REASON product LS-203 is incorrect. It should be LS-232. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE Healthcare Definium 8000 Digital Radiographic System RECALL NUMBER # Z-1882-2008 CODE 0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000114134VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896Ë4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004Ë5, 00000TA42007-4, 00000TA42020-3, 00000TA42025Ë4, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7, 00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6, 00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8, 00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9, 00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7, 00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3, 00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4, 00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5, 00001014936WK7, 00001016147WK9 MANUFACTURED & RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 454 units DISTRIBUTION Nationwide and Internationally REASON Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs readings reported from the system could be up to ten times higher than what was actually exposed to the patient. Occurrence is limited to the first exposure after the focal spot is switched from small to large. The generator incorrectly applies the small filament limit to the large focal spot, which can cause the large focal spot to produce less current. Subsequent large focal spot exposures will not exhibit this issue. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis RECALL NUMBER # Z-1822-2008 CODE 00000002047M39, 00000005487M34, 00000096986DP%, 00000100740WK6, 00000TA41882-7, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA42274-8, 00000TA42869-6, 00001004330WK5, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004510WK2, 00001004513WK6, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004768WK6, 00001004770WK2, 00001004772WK8, 00001005020WK1, 00001005022WK7, 00001005024WK3, 00001005030WK0, 00001005031WK8, 00001005035WK9, 00001005181WK1, 00001005182WK9, 00001005188WK6, 00001005260WK3, 00001005339WK5, 00001005758WK6, 00001005914WK5, 00001006042WK4, 00001006474WK9, 00001006635WK5, 00001006637WK1, 00001006638WK9, 00001006668WK6, 00001006871WK6, 00001007161WK1, 00001007166WK0, 00001007403WK7, 00001007404WK5, 00001007480WK5, 00001007536WK4, 00001007644WK6, 00001007650WK3, 00001007907WK7, 00001008312WK9, 00001008314WK5, 00001008497WK8, 00001008684WK1, 00001008807WK8, 00001008813WK6, 00001009140WK3, 00001009143WK7, 00001009145WK2, 00001009216WK1, 00001009268WK2, 00001009375WK5, 00001009380WK5, 00001009382WK1, 00001009709WK5, 00001009818WK4, 00001009875WK4, 00001009934WK9, 00001009976WK0, 00001010085WK7, 00001010099WK8, 00001010161WK6, 00001010239WK0, 00001010294WK5, 00001010295WK2, 00001010297WK8, 00001010431WK3, 00001010488WK3, 00001010524WK5, 00001010628WK4, 00001010629WK2, 00001010687WK0, 00001010693WK8, 00001010695WK3, 00001010906WK4, 00001010907WK2, 00001010964WK3, 00001011084WK9, 00001011085WK6, 00001011092WK2, 00001011215WK9, 00001011285WK2, 00001011289WK4, 00001011386WK8, 00001011455WK1, 00001011488WK2, 00001011490WK8, 00001011647WK3, 00001011654WK9, 00001011700WK0, 00001011712WK5, 00001011822WK2, 00001011825WK5, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011832WK1, 00001012012WK9, 00001012119WK2, 00001012286WK9, 00001012449WK3, 00001012450WK1, 00001012453WK5, 00001012923WK7, 00001013064WK9, 00001013067WK2, 00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013223WK1, 00001013334WK6, 00001013336WK1, 00001013622WK4, 00001014310WK5, 00001014936WK7, 00001016147WK9 MANUFACTURED & RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 127 units DISTRIBUTION Nationwide and Internationally REASON Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover). This lost anatomy cannot be recovered or visualized by retrospective reconstruction processing. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE Definium 8000, model 5135678, Digital Radiographic Systems RECALL NUMBER # Z-1476-2008 PRODUCT b) GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems RECALL NUMBER # Z-1477-2008 CODE a) Serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30, 00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3, 00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0, 00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2, 00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6, 00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2, 00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7, 00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9, 00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1, 00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0, 00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001004884WK1, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005181WK1, 00001005184WK5, 00001005188WK6, 00001005260WK3, 00001005698WK4, 00001005757WK8, 00001005762WK8, 00001005764WK4, 00001005841WK0, 00001005912WK9, 00001006015WK0, 00001006040WK8, 00001006043WK2, 00001006044WK0, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006633WK0, 00001006637WK1, 00001006664WK5, 00001006666WK0, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007165WK2, 00001007166WK0, 00001007192WK6, 00001007476WK3, 00001007478WK9, 00001007498WK7, 00001007499WK5, 00001007517WK4, 00001007525WK7, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007563WK8, 00001007642WK0, 00001007643WK8, 00001007644WK6, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007651WK1, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007776WK6, 00001007781WK6, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008684WK1, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008811WK0, 00001008813WK6, 00001008814WK4, 00001008840WK9, 00001008995WK1, 00001009057WK9, 00001009059WK5, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009140WK3, 00001009142WK9, 00001009144WK5, 00001009145WK2, 00001009147WK8, 00001009213WK8, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009269WK0, 00001009271WK6, 00001009273WK2, 00001009374WK8, 00001009375WK5, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009380WK5, 00001009381WK3, 00001009382WK1, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009609WK7, 00001009707WK9, 00001009708WK7, 00001009709WK5, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009823WK4, 00001009876WK2, 00001009930WK7, 00001009931WK5, 00001009938WK0, 00001009976WK0, 00001009977WK8, 00001009979WK4, 00001010086WK5, 00001010098WK0, 00001010101WK2, 00001010102WK0, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010159WK0, 00001010161WK6, 00001010162WK4, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010240WK8, 00001010243WK2, 00001010291WK1, 00001010292WK9, 00001010293WK7, 00001010295WK2, 00001010296WK0, 00001010297WK8, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010431WK3, 00001010432WK1, 00001010433WK9, 00001010488WK3, 00001010489WK1, 00001010490WK9, 00001010521WK1, 00001010523WK7, 00001010524WK5, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010629WK2, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010695WK3, 00001010696WK1, 00001010723WK3, 00001010804WK1, 00001010904WK9, 00001010906WK4, 00001010907WK2, 00001010908WK0, 00001010962WK7, 00001011079WK9, 00001011081WK5, 00001011085WK6, 00001011086WK4, 00001011088WK0, 00001011091WK4, 00001011092WK2, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011215WK9, 00001011218WK3, 00001011219WK1, 00001011283WK7, 00001011284WK5, 00001011285WK2, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011289WK4, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011387WK6, 00001011388WK4, 00001011389WK2, 00001011449WK4, 00001011452WK8, 00001011454WK4, 00001011485WK8, 00001011486WK6, 00001011488WK2, 00001011489WK0, 00001011490WK8, 00001011491WK6, 00001011494WK0, 00001011495WK7, 00001011496WK5, 00001011630WK9, 00001011631WK7, 00001011632WK5, 00001011633WK3, 00001011634WK1, 00001011635WK8, 00001011643WK2, 00001011648WK1, 00001011654WK9, 00001011697WK8, 00001011700WK0, 00001011703WK4, 00001011715WK8, 00001011716WK6, 00001011821WK4, 00001011822WK2, 00001011824WK8, 00001011825WK5, 00001011826WK3, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011830WK5, 00001011831WK3, 00001011832WK1, 00001011926WK1, 00001011928WK7, 00001011962WK6, 00001012011WK1, 00001012012WK9, 00001012013WK7, 00001012014WK5, 00001012015WK2, 00001012117WK6, 00001012118WK4, 00001012119WK2, 00001012120WK0, 00001012121WK8, 00001012122WK6, 00001012164WK8, 00001012165WK5, 00001012173WK9, 00001012278WK6, 00001012280WK2, 00001012284WK4, 00001012285WK1, 00001012299WK2, 00001012428WK7, 00001012429WK5, 00001012430WK3, 00001012450WK1, 00001012452WK7, 00001012593WK8, 00001012594WK6, 00001012622WK5, 00001012923WK7, 00001012925WK2, 00001012927WK8, 00001012928WK6, 00001012929WK4, 00001012930WK2, 00001012931WK0, 00001013005WK2, 00001013025WK0, 00001013064WK9, 00001013100WK1, 00001013101WK9, 00001013136WK5, 00001013143WK1, 00001013145WK6, 00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4, 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6, 00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV; b) Serial numbers: 00001014958WK1, 100963570, 00000086203DP7, 00000086475DP1, 00000086507DP1, 00000089131DP7, 00000993365WK6, 00000994505WK6, 00000995353WK0, 00000996209WK3, 00000996212WK7, 00000996789WK4, 00001000009WK9, 00001002273WK9, 00001002491WK7, 00001009077WK7, 00001009774WK9, 00001009986WK9, 00001010013WK9, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010062WK6, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1, 00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011014WK6, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2, 00001011328WK0, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6, 00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6, 00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3, 00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1, 00001013969WK9, 00001013970WK7, 00001013974WK9, 00001013976WK4, 00001013977WK2, 00001014092WK9, 00001014093WK7, 00001014095WK2, 00001014097WK8, 00001014098WK6, 00001014099WK4, 00001014279WK2, 00001014280WK0, 00001014392WK3, 00001014394WK9, 00001014395WK6, 00001014397WK2, 00001014398WK0, 00001014549WK8, 00001014550WK6, 00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1, 00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014710WK6, 00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014959WK9, 00001014960WK7, 00001014961WK5, 00001014962WK3, 00001015088WK6, 00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015563WK8, 00001015689WK1, 00002AU53105K0, 00002UA4490WQG, 00002UA4490WQM, 00002UA4490WQV, 00002UA4510C3B, 00002UA4510C3J, 00002UA45200NH, 00002UA45200NM, 00002UA45200NR, 00002UA45200QY, 00002UA50306KL, 00002UA50306KT, 00002UA50306KW, 00002UA50306L6, 00002UA50306L7, 00002UA50306L8, 00002UA50306LD, 00002UA5030PTY, 00002UA5030PTZ, 00002UA5030PV2, 00002UA5040SH5, 00002UA504DSH3, 00002UA504OSH5, 00002UA5050FP7, 00002UA5080W88, 00002UA5080W89, 00002UA5100TCV, 00002UA510147Y, 00002UA51411JC, 00002UA51411JF, 00002UA51411JG, 00002UA51411JM, 00002UA51411JN, 00002UA51411JT, 00002UA51411JY, 00002UA51411JZ, 00002UA51604QS, 00002UA51604QV, 00002UA51604QY, 00002UA51604R2, 00002UA51604R3, 00002UA51604R4, 00002UA51604R6, 00002UA51604R9, 00002UA51604RH, 00002UA51701BZ, 00002UA51701C2, 00002UA51701C5, 00002UA51701C6, 00002UA51701C8, 00002UA51701CH, 00002UA52111XQ, 00002UA52111XR, 00002UA52111XS, 00002UA52111XT, 00002UA52111XV, 00002UA52111XW, 00002UA52111XX, 00002UA5220564, 00002UA5220BKM, 00002UA5220BKP, 00002UA5220BKV, 00002UA5220S5X, 00002UA5220S5Y, 00002UA5220S5Z, 00002UA5220S62, 00002UA5220S63, 00002UA52606Q5, 00002UA52606QC, 00002UA52606QD, 00002UA52707GY, 00002UA52707GZ, 00002UA527115R, 00002UA527115V, 00002UA527115Z, 00002UA5290DD1, 00002UA5290DD2, 00002UA53006LM, 00002UA53006LN, 00002UA53006LP, 00002UA53006LR, 00002UA53006LS, 00002UA53006LT, 00002UA53006LV, 00002UA5320FKJ, 00002UA5320FKM, 00002UA5320FKN, 00002UA5320FKR, 00002UA53405P5, 00002UA53405P7, 00002UA53405P9, 00002UA53405PG, 00002UA5340LCV, 00002UA5340LCY, 00002UA5340VDC, 00002UA5340VDG, 00002UA5340VDK, 00002UA5340VDL, 00002UA535112H, 00002UA5360CBD, 00002UA5360CBG, 00002UA5360CBM, 00002UA5360CBN, 00002UA53707WM, 00002UA53707WQ, 00002UA53707WR, 00002UA53802GP, 00002UA5400VB7, 00002UA5400VB8, 00002UA541113W, 00002UA541113X, 00002UA5411140, 00002UA5411142, 00002UA5411143, 00002UA5411144, 00002UA5411146, 00002UA5411147, 00002UA5411148, 00002UA5411149, 00002UA541114B, 00002UA541114H, 00002UA542046N, 00002UA542046P, 00002UA542046Q, 00002UA542046R, 00002UA542046T, 00002UA542046V, 00002UA5420VPK, 00002UA5420VPM, 00002UA5420VPP, 00002UA5430X4Y, 00002UA5440B2V, 00002UA5440B2W, 00002UA5450SNN, 00002UA5450SNR, 00002UA5450SNY, 00002UA60200GH, 00002UA606KJH4, 00002UA606KJH7, 00002UA615JV3C, 0000USU4350N51, 0000USU4400NXF, 0000USU4400NXJ, 0000USU4400NXQ, 0000USU4400NXV, 0000USU4400NXW, 0000USU4400NXY, 0000USU4400NY0, 00010103324WK3, 0UNK2289299-01, 00000114134VE0 MANUFACTURED & RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 885 systems DISTRIBUTION Nationwide, Italy, Japan, Spain and Turkey REASON Necessary certification labels are missing from the x-ray control. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Stryker Medical Secure II Med/Surg Bed, 115 V, Model 3002 RECALL NUMBER # Z-1685-2008 PRODUCT b) Stryker Medical Epic II Critical Care Bed, 115 V, Model 2030 RECALL NUMBER # Z-1686-2008 PRODUCT c) Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Model 2040 RECALL NUMBER # Z-1687-2008 CODE a) Serial numbers 040915077 through 071116347; b) Serial numbers 0409060501 through 0711096119; c) Serial numbers 0409060516 through 0711096116; MANUFACTURED & RECALLED BY Stryker Medical Division of Stryker Corp., Portage, MI, QUANTITY 66,558 beds DISTRIBUTION Nationwide and Internationally REASON The brakes may not have adequate holding power to lock the bed in place. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE OEC 9600 C-arm Fluoroscopy System RECALL NUMBER # Z-1709-2008 CODE Serial numbers: 69-1484, 69-3633, 69-3707, 69-1266-RC, 6C-0009-S, 62-0134, 69-1332, 69-3582, 69-3324, 69-2816, 62-0117, 69-2154, 65-0221, 69-2620, 69-2556, 69-0150, 69-3741, 62-0082, 62-0367, 62-0110-RC, 69-2574, 69-0313, 69-3774, 69-0108, 69-2878, 69-0195, 69-0028, 69-3580, 62-0473, 69-2035, 69-2881, 69-2775, 69-2234, 62-0261, 6S-0093-C, 69-2639-C, 69-2615, 69-2882, 62-0154, 69-1075, 69-1440, 6S-0044, 69-0357, 69-3130, 69-2699, 69-3876, 62-0086, 69-2716, 6S-0213, 69-2891, 62-0222, 69-2046, 69-2127, 69-2297, 69-2760, 69-2999-RC1, 69-3245, 6S-0137-C, 6S-0051C, 69-1022, 69-3026, 62-0087, 6S-0079-C, 69-0343, 62-0159, 69-0216, 62-0611, 69-2904, 69-3875, 69-3769, 6S-0199, 69-2767, 69-1087, 69-1401, 62-0239, 69-3519, 69-2592, 69-0282, 69-3776, 69-0436, 69-3145, 69-2320, 69-3577, 69-2621, 69-2553, 69-1188-RC, 69-0082, 6S-0228, 69-3833, 69-1009, 69-3668, 6S-0233, 69-0397, 69-2884, 69-1341, 69-0429, 69-3157, 69-0041, 69-3486, 69-1040, 69-2642, 62-0203, 69-3808, 69-0432, 69-3792, 62-0132, 62-0350, 69-2814, 65-0087-C, 6S-0086-C, 6S-0170, 66-0046, 69-0482, 69-2983, 69-335C, 69-2542, 69-2436-RC, 69-2634, 69-2879, 69-3866, 62-0481-C, 62-0600, 69-2916, 69-3368, 69-0304, 69-2781, 69-3409, 69-0243, 69-3258, 62-0100, 69-1348, 69-2222, 69-2126, 69-2293, 69-3512, 69-3888, 69-2545, 69-0094, 69-2873, 69-2870, 69-2874, 6S-0251, 69-3467-C, 69-2702, 69-1391, 69-3811, 6S-0156, 6S-0063, 69-1461, 69-3260, 69-3716, 69-3084, 69-2539, 69-3907, 62-0127, 6C-0042-RF, 69-3113, 69-3766, 69-0479, 62-0365, 69-2227, 69-3835-RC, 69-0066, 6S-0283, 69-1306, 69-2562, 69-1001, 69-1437, 69-3202, 69-0119, 69-2617, 6C-0017-RC, 69-1020, 69-2263, 69-0086, 69-3397, 62-0347, 69-0042, 62-0429, 69-3476, 69-0452, 69-0382, 6C-0015, 62-0126, 62-0596, 69-1454, 69-0360-RC, 69-2913, 69-1416, 69-2567, 69-2675, 62-0051, 69-2885, 6S-0197, 69-2268, 69-2269, 69-0068, 69-3232, 69-2348, 69-3312, 69-2611-C, 69-2591, 69-3837, 69-3618, 69-0130, 69-2405, 62-0604, 69-2828, 69-0289, 69-3740, 69-1227, 69-2968, 69-0135, 69-2654-C, 69-2941, 69-2142, 62-0054, 69-3705, 6S-0217, 69-1189, 69-2271, 69-0093, 6S-0301, 69-2521, 69-0205-RC, 69-2706, 69-3481, 69-2031, 62-0223, 69-1280, 69-1427-RC, 69-2773-RC, 6S-0128, 69-2725, 69-3804, 69-1472-RC, 69-0098, 69-3162, 69-0156, 62-0468, 69-3899, 69-2684, 69-0414, 69-1508, 69-0283, 69-2299-RC, 69-2079, 69-3654, 69-1413, 69-2285, 62-0560, 69-0183, 69-1027-RM, 62-0337, 69-0026, 69-3755, 69-3856, 69-2748, 69-2746, 65-0297, 69-3821, 69-2533, 69-3585, 69-3564, 69-2756, 69-0021, 69-2616, 69-1411, 69-0384, 69-3191, 69-3639-RC, 69-1011, 69-3807, 69-3470, 69-1173, 69-3253, 69-3541, 69-2623, 69-2625-C, 69-2758, 62-0073, 69-0081, 6S-0208, 6S-0209-C, 69-0020, 69-1486, 69-3640, 6S-0141, 69-2061-RC, 6S-0144, 69-3719, 69-2479, 69-3361, 69-2792, 62-0274, 69-2368, 69-2059, 69-2963-RC, 6S-0161-C, 69-1324, 69-1433, 69-2548, 69-3438, 62-0155, 62-0377, 6S-0184-C, 62-0016, 69-2589, 62-0340, 62-0040, 6S-0101-C, 69-2194, 69-2024, 69-3077, 69-0427, 69-3190, 69-0097, 69-2581, 69-2550, 69-3608, 6S-0114, 69-0402, 62-0081, 69-1405, 6S-0250, 69-3032, 69-1449, 69-2583, 69-2544, 69-1383, 6S,0106, 69-2053, 6S-0050, 69-2391, 69-3878, 69-0474, 69-3902, 69-1404, 69-2943, 69-0060, 6S-0055-C-RC, 62-0092, 69-2549, 62-0441, 62-0161, 69-3223, 69-3212, 69-1006, 62-0108, 69-3471, 6S-0256, 69-1496, 69-2025, 6S-0004, 69-3686, 69-3388, 69-1032, 69-3053, 69-3441, 62-0068, 69-1386, 69-3905, 69-2596-C, 69-2338, 69-2115, 69-0337, 69-2034, 69-2686, 69-3429, 69-2764, 62-0385, 69-3777-RC, 69-3088, 69-2701, 69-3767, 62-0474, 69-2692, 69-2555, 6S-0002, 6S-0133, 69-0234, 69-2375, 6C-0004, 69-0100, 69-3612, 69-0172, 69-3183, 69-2597-C, 69-0027, 69-1264, 62-0076, 6C-0005, 69-2441, 62-0047, 62-0136, 69-1334, 69-2413, 69-3198, 69-3259, 69-2323, 69-1392, 69-3657, 69-3825, 69-1441, 62-0085, 69-2033, 62-0578, 69-2653-C, 69-0386, 62-0069, 69-2783, 69-1381, 6S-0131, 62-0160, 69-3841, 69-2543, 69-2485, 69-1477, 69-2278, 69-3242, 69-0069, 69-2827-RC, 69-3733-RC, 69-2203, 69-0087, 62-0518, 69-1473, 69-3854, 69-1042, 69-0101, 69-0139, 69-0155, 69-0453, 6S-0132, 69-2613, 69-2851, 6S-0181, 6S-0082-C, 62-0496, 69-1390, 69-3892, 69-3166, 69-2063, 69-3020, 6S-0061-RC, 6C-0023-RC, and 6S-0187 MANUFACTURED & RECALLED BY OEC Medical Systems, Inc., Salt Lake City, UT QUANTITY 700 units DISTRIBUTION Nationwide REASON Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EER verification and/or calibration were performed after collimator replacement. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT 1) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2555-020-05 RECALL NUMBER # Z-1480-2008 PRODUCT 2) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft Drain, 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; REF 00-2555-030-05 RECALL NUMBER # Z-1481-2008 PRODUCT 3) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2555-040-05 RECALL NUMBER # Z-1482-2008 PRODUCT 4) Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; REF 00-2555-050-05 RECALL NUMBER # Z-1483-2008 PRODUCT 5) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain, sterile, latex free, Rx only; REF 00-2555-060-05 RECALL NUMBER # Z-1484-2008 PRODUCT 6) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2500-000-10 RECALL NUMBER # Z-1485-2008 PRODUCT 7) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2500-700-10 RECALL NUMBER # Z-1486-2008 PRODUCT 8) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2505-000-10 RECALL NUMBER # Z-1487-2008 PRODUCT 9) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2505-700-10 RECALL NUMBER # Z-1488-2008 PRODUCT 10) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; REF 00-2550-001-10 RECALL NUMBER # Z-1489-2008 PRODUCT 11) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2550-002-10 RECALL NUMBER # Z-1490-2008 PRODUCT 12) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 3/16" Drain, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2550-003-10 RECALL NUMBER # Z-1491-2008 PRODUCT 13) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2550-004-10 RECALL NUMBER # Z-1492-2008 PRODUCT 14) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2550-702-10 RECALL NUMBER # Z-1493-2008 PRODUCT 15) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2550-703-10 RECALL NUMBER # Z-1494-2008 PRODUCT 16) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection Control Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2550-704-10 RECALL NUMBER # Z-1495-2008 PRODUCT 17) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; REF 00-2557-000-10 RECALL NUMBER # Z-1496-2008 PRODUCT 18) Zimmer Hemovac Wound Drainage Device, 100 ml Hemovac Mini Evacuator, sterile, latex free, Rx only; REF 00-2568-000-10 RECALL NUMBER # Z-1497-2008 PRODUCT 19) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar (4"), 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-000-10 RECALL NUMBER # Z-1498-2008 PRODUCT 20) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-040-10 RECALL NUMBER # Z-1499-2008 PRODUCT 21) Zimmer Hemovac Wound Drainage Device, 400 ml EVAC 1/4" DR w/troc spec., 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-700-10 RECALL NUMBER # Z-1500-2008 PRODUCT 22) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC w/trocar, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; REF 00-2595-000-10 RECALL NUMBER # Z-1501-2008 PRODUCT 23) Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP EVAC w/O.P. Adapter Component Kit, to be used with OrthoPAT post op suction set, sterile, latex free, Rx only; REF 00-2696-000-10 RECALL NUMBER # Z-1502-2008 PRODUCT 24) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-5300-000-05 and 00-5300-000-10 RECALL NUMBER # Z-1503-2008 PRODUCT 25) Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx only; REF 00-5300-004-10 RECALL NUMBER # Z-1504-2008 PRODUCT 26) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-5305-000-05 and 00-5305-000-10 RECALL NUMBER # Z-1505-2008 PRODUCT 27) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar, 3,2mm, 10Fr, Si, 107cm, medium, sterile, latex free, Rx only; REF 00-5340-000-05 and 00-5340-000-10 RECALL NUMBER # Z-1506-2008 PRODUCT 28) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" MP SIL w/trocar, 4, 8mm, 15Fr, Si, 107cm, soft, sterile, latex free, Rx only; REF 00-5341-000-05 and 00-5341-000-10 RECALL NUMBER # Z-1507-2008 PRODUCT 29) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP SIL w/trocar, 6,4mm, 19Fr, Si, 107cm, large, sterile, latex free, Rx only; REF 00-5345-000-10 RECALL NUMBER # Z-1508-2008 PRODUCT 30) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-5390-040-10 RECALL NUMBER # Z-1509-2008 CODE All lots manufactured on or before 1/18/08. Product has a 5 year expiration period. MANUFACTURER Zimmer Orthopedic Surgical Products, Dover, OH RECALLED BY Zimmer, Inc., Warsaw, IN QUANTITY 377,707 packages DISTRIBUTION Nationwide and Internationally REASON The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII: C Pasteurized Monoclonal Antibody Purified; an Rx product, for intravenous administration only, store at 2-8 degrees C, US License No. 1767; NDC #0053-7656-04 RECALL NUMBER # B-1892-08 CODE Lot numbers: J91504, exp. April 25, 2010; J91604, exp. April 30, 2010; J91705, exp. May 02, 2010; J91806, exp. June 9, 2010 MANUFACTURED & RECALLED BY CSL Behring LLC, Kankakee, IL QUANTITY 650 vials DISTRIBUTION CA, FL, GA, KS, ND, PA, Trinidad and Tobago REASON Monoclate-P lots, which did not meet the potency assay requirements for stability testing at 3 months at 5 degrees C storage, were distributed. ---------------------------------------------------------------------------