NRAC Issue #1668 ADDENDUM February 5, 2008 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Siemans Simview 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153 RECALL NUMBER # Z-0281-2008 PRODUCT b) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No. 54 96 992 RECALL NUMBER # Z-0282-2008 PRODUCT c) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984 RECALL NUMBER # Z-0283-2008 PRODUCT d) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016 RECALL NUMBER # Z-0284-2008 PRODUCT e) Siemans Mevasim, with patient table, Part No: 44 81 586, and without patient table Part No: 44-81-669 RECALL NUMBER # Z-0285-2008 CODE a) Serial Numbers: 4164, 4062, 4114, 4037, 4155, 4125, 4180, 4096, 4064, 4107, 4145, 4144, 4143, 4081, 4172, 4152, 4090, 4161, 4181, 4093, 4066, 4054, 4091, 4068, 4128, 4179, 4019, 4023, 4117, 4094, 4015, 4083, 4174, 4074, 4082, 4011, 4078, 4034, 4063, 4025, 4171, 4086, 4134, 4029, 4002, 4003, 4004, 4027, 4053, 4061, 4118, 4123, 4124, 4008, 4009, 4010, 4014, 4016, 4017, 4021, 4022, 4024, 4026, 4031, 4032, 4035, 4043, 4059, 4072, 4075, 4076, 4078, 4085, 4087, 4092, 4095, 4098, 4102, 4104, 4105, 4108, 4109, 4110, 4111, 4112, 4115, 4116, 4130, 4136, 4142, 4150, 4153, 4156, 4173, 70001004511, 40000296842, 4099, 4147, 4100, 4154, 4044, 4119, 4121, 4122, 4131, 4139, 4185, 4020, 4030, 4036, 4079, 4135, 4167, 4077, 4039, 4071, 4120, 41514127, 4176, 4097, 4049, 4046, 4070, 4084, 4138, 4160, 4165, 4028, 4042, 4101, 410, 4158, 4045, 4065, 4060, 4088, 4177, 4073, 4113, 4175, 4141, 4040, 4137, and 4052; b) Serial Numbers: 6032, 6005, 6068, 6035, 6046, 6012, 6080, 6019, 6029, 6021, 6024, 6025, 6053, 6060, 6015, 6059, 6002, 6004, 6007, 6011, 6014, 6023, 6030, 6042, 6049, 6062, 4190, 6033, 6039, 6061, 6086, 6056, 6028, 3654, 6020, 6069, 6085, 6088, 6095, 6103, 6104, 6070, 6099-1, 6048, 6006, 1236, 6092, and 6054; c) Serial Numbers: 6013, 6003, 6078, and 6676; d) Serial Numbers: 6018, 6001, 6008, 6067, 6037, 6038, 6059, 6041, 6047, 6017, 6027, 6036, 6040, 6050, 1256, 6082, 6056, 6064, 6083, 6034, 6044, 6055, 6058, 6028, 6090, 6105, 2255, 6079, 6089, 6073, 6052, 6077, 6072, and 6066 e) All Serial Numbers (1182 and higher): 1501, 1516, 1213, 1225, 1200, 1518, 1201, 1520, 1246, 1228, 1197, 1202, 1224, 1231, 1191, 1184, and 1506, "MEVASIM", Serial Numbers (1182 and higher): 1204, 1192, 1216, 1502, 1230, 1220, 1209, 1233, 1510, 1241, 1194, 1514, 1523, 1212, 1222, 1252, 2012, 2010-335-217, 1249, 4000296842, S1144, 01069H400, 1503, 1517, 1251, 1238, 1274, 1509, and 1519 MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc., Concord, CA QUANTITY 287 units DISTRIBUTION Nationwide and Internationally REASON Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Philips Page Writer Touch Cardiograph, Model: 860284 RECALL NUMBER # Z-0124-2008 CODE Serial Numbers: US10603477 US60711180 US70711234 US80711276 US80711348 US80711386 US80711459 US10603478 US60711181 US70711235 US80711283 US80711349 US80711387 US80711460 US10603491 US60711182 US70711236 US80711284 US80711350 US80711388 US80711461 US10603493 US60711183 US70711241 US80711285 US80711351 US80711389 US80711462 US10603494 US60711184 US80503039 US80711286 US80711352 US80711390 US80711463 US10603495 US60711185 US80503049 US80711287 US80711353 US80711391 US90503082 US10603496 US60711186 US80711244 US80711288 US80711354 US80711392 US90503117 US10603497 US70711197 US80711245 US80711289 US80711355 US80711393 US90503119 US10603498 US70711199 US80711246 US80711290 US80711356 US80711394 US90503120 US10603499 US70711201 US80711247 US80711291 US80711357 US80711395 US90503121 US10603530 US70711205 US80711248 US80711292 US80711358 US80711396 US90503126 US10710463 US70711207 US80711249 US80711293 US80711359 US80711398 US90503127 US10710464 US70711208 US80711250 US80711294 US80711360 US80711399 US90503128 US10710465 US70711209 US80711251 US80711295 US80711361 US80711400 US90503129 US50502760 US70711210 US80711252 US80711296 US80711362 US80711402 US90503143 US50710968 US70711211 US80711253 US80711297 US80711363 US80711403 US90503148 US60502824 US70711212 US80711254 US80711298 US80711364 US80711404 US90503149 US60502825 US70711213 US80711255 US80711299 US80711365 US80711405 US90503150 US60502826 US70711214 US80711256 US80711300 US80711366 US80711406 US90503151 US60711064 US70711215 US80711257 US80711301 US80711367 US80711407 US90503152 US60711065 US70711216 US80711258 US80711302 US80711368 US80711408 US90503153 US60711067 US70711217 US80711259 US80711303 US80711369 US80711409 US90503154 US60711068 US70711218 US80711260 US80711304 US80711370 US80711411 US90503155 US60711070 US70711219 US80711261 US80711305 US80711371 US80711412 US90503156 US60711071 US70711220 US80711262 US80711306 US80711372 US80711413 US90503157 US60711073 US70711221 US80711263 US80711307 US80711373 US80711416 US90503158 US60711074 US70711222 US80711264 US80711308 US80711374 US80711417 US90503159 US60711075 US70711223 US80711265 US80711309 US80711375 US80711418 USD0301315 US60711076 US70711224 US80711266 US80711310 US80711376 US80711419 USD0610313 US60711077 US70711225 US80711267 US80711339 US80711377 US80711420 USN0301134 US60711078 US70711226 US80711268 US80711340 US80711378 US80711421 USN0400155 US60711079 US70711227 US80711269 US80711341 US80711379 US80711422 USN0402121 US60711080 US70711228 US80711270 US80711342 US80711380 US80711431 USN0402126 US60711081 US70711229 US80711271 US80711343 US80711381 US80711439 USN0402127 US60711176 US70711230 US80711272 US80711344 US80711382 US80711440 USN0402128 US60711177 US70711231 US80711273 US80711345 US80711383 US80711455 USN0402129 US60711178 US70711232 US80711274 US80711346 US80711384 US80711457 USN0610295 US60711179 US70711233 US80711275 US80711347 US80711385 US80711458 USO0610104 MANUFACTURED & RECALLED BY Philips Medical Systems, Andover, MA QUANTITY 266 units DISTRIBUTION Nationwide and Internationally REASON Incorrect display: when using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length RECALL NUMBER # Z-0935-2008 PRODUCT b) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-89. 6F AR MOD (Single Pack). Distal curve AR MOD. 100 cm length RECALL NUMBER # Z-0936-2008 PRODUCT c) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length RECALL NUMBER # Z-0937-2008 PRODUCT d) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-195. 6F LCB (5-pack). Distal curve LCB. 100 cm length RECALL NUMBER # Z-0938-2008 PRODUCT e) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-202. 6F IM T (t-pack). Distal curve IM T. 100 cm length RECALL NUMBER # Z-0939-2008 PRODUCT f) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-86. 6F AR2 (5-pack). Distal curve AR2. 100 cm length RECALL NUMBER # Z-0940-2008 PRODUCT g) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-201. 6F IM (5-pack). Distal curve IM. 100 cm length RECALL NUMBER # Z-0941-2008 PRODUCT h) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-302. 6F MULTI PIG 155 (5-pack). Distal curve FL4, FR4, PIG 155. 100 and 110 cm length RECALL NUMBER # Z-0942-2008 PRODOUCT i) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-98. 6F AL2 (5-pack). Distal curve AL2. 100 cm length RECALL NUMBER # Z-0943-2008 PRODUCT j) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-01. 6F FR3.5 (5-pack). Distal curve FR3.5. 100 cm RECALL NUMBER # Z-0944-2008 PRODUCT k) Boston Scientific Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length RECALL NUMBER # Z-0945-2008 CODE a) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-301/H749165993010/H749165993010/0020032538 and 16599-301/H749165993010/H749165993010/002003517 b) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-89/H74916599890/H74916599890/0020032541 c) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-04/H74916599042/H74916599040/0020033644; and 16599-04/H74916599042/H74916599040/0020036932 d) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-195/H749165991952/H749165991950/0020033662 e) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-202/H749165992022/H749165992020/0020033665 f) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-86/H74916599862/H74916599860/0020033690 g) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-201/H749165992012/H749165992010/0020035115 h) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-302/H749165993022/H749165993020/0020035141 i) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-98/H74916599982/H74916599980/0020035149 j) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-01/H74916599012/H74916599010/0020036925 k) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No.: 16599-03/H74916599032/H74916599030/0020036931 MANUFACTURER Pacific Device De Mexico S A De C V, Tijuana B C Mexico RECALLED BY Boston Scientific, Maple Grove, MN QUANTITY 211 single units DISTRIBUTION Nationwide REASON Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) RECALL NUMBER # Z-0690-2008 PRODUCT b) GE Innova 3100/3100 IQ Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) RECALL NUMBER # Z-0691-2008; PRODUCT c) GE Innova 4100/4100 IQ (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) RECALL NUMBER # Z-0692-2008 CODE a) 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 0850060723 DZ1006VA01 0910162009 0910162010 0910162011 0910162012 0910163011 0910163014 0910162013 010120RX44 0002673668 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 082416100014 082416150002 082416100011 082416130026 082416010005 082416010007 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100009 082416100012 082416100017 082416120008 082416130016 082416130019 082416130023 082416130024 082416160007 082416180003 082416200004 082416210007 082416220010 082416120009 2664023INNOVA CS1118VA03 CS1006VA04 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01 H2077VAS27 0828160007 0002644132 08301600206936 083016002101586 083016102100795 083016202101036 083016202101917 083016242100936 083016282101457 083016602101386 083016802100516 083016802100866 083016802100916 083016862101407 083016862101656 083016862101916 83016802100337 83016862100377 083016602101807 083016802101197 "08301680520687 (temp 0002673438)" 083016822101187 0835160017 0835160018 IE1100VA02 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 YV0053 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0080 YV0081 YV0100 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 LT4000VA04 0002679402 0002684003X 644INNOVA21 83INNOVA2588441 MA1004VA02 NO1009VA03 600151VA01 600042VA03 PER00218 0002674834 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 SA1011VA01 SA1054VA02 0847160002 0847160003 FEB52055 ME612436 CEE15663 SD1038VA01 A004RX01 A020RX13 468668XR01 SY1001VA02 SY2005VA01 0853060191 853060197 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100 717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2 PRESBYDEP 303839CL2 252384CATH1 303788CL1 4436432100 4107872100 8184092100 864255SFCL2 219932DCL2 305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 608775NOVA2 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1 212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21 253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3 305682IN2X 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 423495MCATH1 501257VALAB1 508335CA1 508856IN21 509575YM2100 516562INNOVA2A 518243LAB1 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 608775NOVA1 610250INNOVA1 610250INNOVA3 610776INNOVA21 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 706291CLIN1 713375U2100 713375UCA 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815741CA1000 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 858554INNOVA3 864255SFCL1 904597CATH 910343EP1 910343EP2 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508941IN21 508335INNOVA 843692CATH3 828213IN21 901765EP 410554INNOVA4 and 410554INNOVA3; b) HU1099VA04 0850060719 0850060724 0850060726 0850060727 0850060728 378INV31 0910064009 0910163012 0910163013 0910163015 BE5003VA02 140024RX09 BA4080VA01 2573329 2667313 BG4549VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416160012 082416170002 082416040017 082416070004 2625365INNOVA 2645993INNOVA CS1006VA03 0002655786 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 GE1005VA01 HC4348XR01 HC1536XR04 00203VAS01 01367VAS02 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 YV0036 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 KW1055VA01 0834160003 83INNOVA1188379 0920169007 2048000INNOVA 2664627INNOVA PL1082VA01 600098VA01 RU2457VA01 RU1482VA02 RU1475VA01 RU1550VA01 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 0853060194 01012VAS01 41018VAS01 58002VAS01 60001VAS01 215576INNOVA1 518525LAB1 760242CATH1 404686CRI3 4103623100 281420LAB23100 541382CV3 205783BCL5 540953INNOVA 2035763100 508941IN1 717217INN31 843797TCL2 573815BCR1 361980INNOVA2 214590PH3100 313593IC2 561266IN31 303629CL4 303629EP 3027443100 7018573100 303788CL2 812450EP1 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 808547QCV2A 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 765453INNOVA1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 8508573100 ECXV1406C 413447CATH BPINNOVA3R 207662CL4 207879CL131 770991CL3 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 417269SCLD 7278253100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 8019643100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 and 388567772VASMET; c) 0850060718 0850060720 0850060721 0850060722 0850060725 514842AINNOVA 613548INNOVA3 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 FI1015VA02 M1230007 HC0220XR07 00490VAS02 01278VAS01 10091VAS01 083006202101017 IE1100VA01 IL1043VA01 A5102671 A5163317 A5605732 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 KW1001VA03 KW1001VA04 KW1018VA04 LB1037VA01 600042VA02 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 SA1005VA06 0002603739 0002603828 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100 719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 804594CATH 239939INNOVA 574535IN41 252847PRS3 864255SF4100 305823IN4100 7137764100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 304424CCINOVA 309655FSP1A 4134474100 5033704100 509474SH41 813745INTV 813972INTV 201541SP1 229228INNOV41V 281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100 508856OR41 314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI 419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100 PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E 423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 and 509575YM4100 MANUFACTURER GE Medical Systems, SCS, Buc Cedex, France RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 868 units DISTRIBUTION Nationwide and Internationally REASON Frozen Image Problems: during an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the pedal. During an intervention, an operator could be misled to believe that the "frozen" image is instead a live dynamic image. This translates to an inability to see/control stent, endo-prosthesis placement, glue injection, or other device placement during an intervention and thus an increased patient risk of catheter, guidewire, glue an/or device misplacement. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Spacelabs Medical Ultraview Multigas Analyzer, Model 91518 RECALL NUMBER # Z-0660-2008 CODE 1518-000511, 1518-000512, 1518-000080, 1518-000079, 1518-000078, 1518-000077, 1518-000074, 1518-000073, 1518-000071, 1518-000072, 1518-000028, 1518-000086, 1518-000083, 1518-000048, 1518-000015, 1518-000012, 1518-000011, 1518-000009, 1518-000065, 1518-000020, 1518-000022, 1518-000066, 1518-000068, 1518-000492, 1518-000473, 1518-000476, 1518-000483, 1518-000482, 1518-000481, 1518-000480, 1518-000479, 1518-000478, 1518-000477, 1518-000474, 1518-000467, 1518-000472, 1518-000471, 1518-000470, 1518-000469, 1518-000468, 1518-000475, 1518-000634, 1518-000562, 1518-000588, 1518-000589, 1518-000590, 1518-000591, 1518-000592, 1518-000593, 1518-000594, 1518-000595, 1518-000602, 1518-000603, 1518-000609, 1518-000610, 1518-000587, 1518-000597, 1518-000574, 1518-000584, 1518-000561, 1518-000564, 1518-000563, 1518-000565, 1518-000566, 1518-000573, 1518-000575, 1518-000576, 1518-000577, 1518-000578, 1518-000582, 1518-000583, 1518-000567, 1518-000145, 1518-000144, 1518-000143, 1518-000142, 1518-000281, 1518-000286, 1518-000282, 1518-000283, 1518-000278, 1518-000285, 1518-000277, 1518-000276, 1518-000275, 1518-000280, 1518-000521, 1518-000522, 1518-000598, 1518-000119, 1518-000664, 1518-000659, 1518-000660, 1518-000661, 1518-000662, 1518-000663, 1518-000665, 1518-000667, 1518-000668, 1518-000658, 1518-000669, 1518-000666, 1518-000656, 1518-000655, 1518-000654, 1518-000653, 1518-000650, 1518-000649, 1518-000648, 1518-000647, 1518-000645, 1518-000635, 1518-000633, 1518-000657, 1518-000713, 1518-000709, 1518-000714, 1518-000712, 1518-000711, 1518-000710, 1518-000707, 1518-000706, 1518-000705, 1518-000704, 1518-000703, 1518-000708, 1518-000039, 1518-000059, 1518-000056, 1518-000053, 1518-000052, 1518-000051, 1518-000049, 1518-000041, 1518-000032, 1518-000047, 1518-000254, 1518-000257, 1518-000263, 1518-000265, 1518-000272, 1518-000273, 1518-000220, 1518-000672, 1518-000623, 1518-000622, 1518-000632, 1518-000631, 1518-000630, 1518-000629, 1518-000627, 1518-000626, 1518-000624, 1518-000613, 1518-000621, 1518-000606, 1518-000612, 1518-000614, 1518-000617, 1518-000625, 1518-000619, 1518-000604, 1518-000620, 1518-000611, 1518-000445, 1518-000448, 1518-000447, 1518-000446, 1518-000267, 1518-000271, 1518-000227, 1518-000646, 1518-000682, 1518-000558, 1518-000559, 1518-000556, 1518-000557, 1518-000560, 1518-000382, 1518-000393, 1518-000384, 1518-000394, 1518-000383, 1518-000691, 1518-000689, 1518-000690, 1518-000308, 1518-000309, 1518-000179, 1518-000165, 1518-000174, 1518-000177, 1518-000178, 1518-000180, 1518-000182, 1518-000184, 1518-000185, 1518-000188, 1518-000173, 1518-000186, 1518-000170, 1518-000166, 1518-000167, 1518-000164, 1518-000163, 1518-000162, 1518-000161, 1518-000160, 1518-000159, 1518-000158, 1518-000171, 1518-000216, 1518-000335, 1518-000340, 1518-000341, 1518-000342, 1518-000343, 1518-000332, 1518-000358, 1518-000353, 1518-000517, 1518-000520, 1518-000518, 1518-000516, 1518-000509, 1518-000506, 1518-000508, 1518-000519, 1518-000507, 1518-000515, 1518-000168, 1518-000266, 1518-000268, 1518-000312, 1518-000310, 1518-000311, 1518-000386, 1518-000387, 1518-000388, 1518-000540, 1518-000542, 1518-000541, 1518-000535, 1518-000538, 1518-000536, 1518-000539, 1518-000537, 1518-000581, 1518-000579, 1518-000729, 1518-000730, 1518-000671, 1518-000670, 1518-000046, 1518-000084, 1518-000081, 1518-000076, 1518-000075, 1518-000055, 1518-000030, 1518-000067, 1518-000398, 1518-000451, 1518-000370, 1518-000375, 1518-000374, 1518-000373, 1518-000371, 1518-000369, 1518-000368, 1518-000367, 1518-000361, 1518-000359, 1518-000372, 1518-000360, 1518-000366, 1518-000362, 1518-000363, 1518-000364, 1518-000365, 1518-000427, 1518-000434, 1518-000457, 1518-000450, 1518-000454, 1518-000616, 1518-000157, 1518-000155, 1518-000156, 1518-000738, 1518-000743, 1518-000742, 1518-000741, 1518-000739, 1518-000737, 1518-000736, 1518-000735, 1518-000734, 1518-000733, 1518-000732, 1518-000740, 1518-000452, 1518-000453, 1518-000489, 1518-000596, 1518-000608, 1518-000599, 1518-000600, 1518-000247, 1518-000529, 1518-000534, 1518-000533, 1518-000532, 1518-000531, 1518-000528, 1518-000527, 1518-000526, 1518-000525, 1518-000524, 1518-000523, 1518-000530, 1518-000435, 1518-000436, 1518-000125, 1518-000129, 1518-000130, 1518-000132, 1518-000462, 1518-000336, 1518-000337, 1518-000510, 1518-000605, 1517-000605, 1518-000683, 1518-000684, 1518-000195, 1518-000206, 1518-000205, 1518-000181, 1518-000203, 1518-000207, 1518-000200, 1518-000199, 1518-000198, 1518-000197, 1518-000196, 1518-000194, 1518-000193, 1518-000192, 1518-000191, 1518-000190, 1518-000189, 1518-000183, 1518-000175, 1518-000172, 1518-000187, 1518-000301, 1518-000304, 1518-000303, 1518-000215, 1518-000319, 1518-000400, 1518-000376, 1518-000317, 1518-000318, 1518-000322, 1518-000323, 1518-000325, 1518-000035, 1518-000009, 1518-000485, 1518-000002, 1518-000035, 1518-000033, 1518-000005, 1518-000006, 1518-000023, 1518-000062, 1518-000235, 1518-000238, 1518-000234, 1518-000232, 1518-000233, 1518-000231, 1518-000243, 1518-000440, 1518-000449, 1518-000685, 1518-000328, 1518-000324, 1518-000219, 1518-000217, 1518-000218, 1518-000331, 1518-000333, 1518-000334, 1518-000403, 1518-000404, 1518-000406, 1518-000402, 1518-000442, 1518-000443, 1518-000493, 1518-000503, 1518-000504, 1518-000502, 1518-000651, 1518-000652, 1518-000720, 1518-000721, 1518-000464, 1518-000465, 1518-000466, 1518-000488, 1518-000057, 1518-000048, 1518-000636, 1518-000637, 1518-000120, 1518-000124, 1518-000123, 1518-000121, 1518-000122, 1518-000038, 1518-000040, 1518-000043, 1518-000044, 1518-000050, 1518-000036, 1518-000013, 1518-000045, 1518-000029, 1518-000024, 1518-000016, 1518-000008, 1518-000003, 1518-000034, 1518-000019, 1518-000349, 1518-000354, 1518-000355, 1518-000389, 1518-000397, 1518-000399, 1518-000110, 1518-000111, 1518-000380, 1518-000264, 1518-000293, 1518-000292, 1518-000294, 1518-000295, 1518-000296, 1518-000297, 1518-000356, 1518-000357, 1518-000225, 1518-000245, 1518-000226, 1518-000223, 1518-000222, 1518-000228, 1518-000113, 1518-000114, 1518-000385, 1518-000313, 1518-000314, 1518-000112, 1518-000105, 1518-000102, 1518-000103, 1518-000458, 1518-000459, 1518-000460, 1518-000461, 1518-000463, 1518-000007, 1518-000001, 1518-000063, 1518-000061, 1518-000069, 1518-000070, 1518-000099, 1518-000100, 1518-000101, 1518-000134, 1518-000135, 1518-000136, 1518-000137, 1518-000344, 1518-000345, 1518-000455, 1518-000456, 1518-000496, 1518-000497, 1518-000495, 1518-000699, 1518-000701, 1518-000700, 1518-000697, 1518-000696, 1518-000695, 1518-000698, 1518-000702, 1518-000126, 1518-000128, 1518-000484, 1518-000487, 1518-000486, 1518-000116, 1518-000117, 1518-000118, 1518-000291, 1518-000688, 1518-000692, 1518-000693, 1518-000694, 1518-000339, 1518-000543, 1518-000544, 1518-000545, 1518-000580, 1518-000585, 1518-000586, 1518-000601, 1518-000607, 1518-000133, 1518-000139, 1518-000140, 1518-000141, 1518-000726, 1518-000727, 1518-000444, 1518-000209, 1518-000210, 1518-000211, 1518-000213, 1518-000299, 1518-000437, 1518-000438, 1518-000439, 1518-000302, 1518-000115, 1518-000138, 1518-000298, 1518-000628, 1518-000131, 1518-000262, 1518-000244, 1518-000248, 1518-000249, 1518-000252, 1518-000253, 1518-000255, 1518-000256, 1518-000258, 1518-000259, 1518-000261, 1518-000270, 1518-000236, 1518-000242, 1518-000260, 1518-000202, 1518-000241, 1518-000201, 1518-000204, 1518-000208, 1518-000212, 1518-000214, 1518-000229, 1518-000239, 1518-000237, 1518-000169, 1518-000240, 1518-000224, 1518-000176, 1518-000441, 1518-000548, 1518-000505, 1518-000686, 1518-000715, 1518-000716, 1518-000717, 1518-000718, 1518-000719, 1518-000230, 1518-000221, 1518-000570, 1518-000379, 1518-000390, 1518-000377, 1518-000378, 1518-000391, 1518-000395, 1518-000251, 1518-000554, 1518-000127, 1518-000728, 1518-000305, 1518-000082, 1518-000104, 1518-000106, 1518-000107, 1518-000108, 1518-000109, 1518-000037, 1518-000042, 1518-000054, 1518-000085, 1518-000088, 1518-000745, 1518-000744, 1518-000426, 1518-000422, 1518-000423, 1518-000421, 1518-000424, 1518-000425, 1518-000428, 1518-000429, 1518-000430, 1518-000431, 1518-000433, 1518-000415, 1518-000420, 1518-000432, 1518-000408, 1518-000419, 1518-000417, 1518-000405, 1518-000409, 1518-000410, 1518-000411, 1518-000413, 1518-000414, 1518-000418, 1518-000401, 1518-000416, 1518-000396, 1518-000412, 1518-000017, 1518-000021, 1518-000290, 1518-000279, 1518-000284, 1518-000287, 1518-000288, 1518-000289, 1518-000615, 1518-000618, 1518-000572, 1518-000571, 1518-000641, 1518-000642, 1518-000643, 1518-000644, 1518-000640, 1518-000306, 1518-000568, 1518-000638, 1518-000639, 1518-000687, 1518-000553, 1518-000498, 1518-000499, 1518-000500, 1518-000246, 1518-000679, 1518-000680, 1518-000681, 1518-000678, 1518-000407, 1518-000307, 1518-000327, 1518-000316, 1518-000315, 1518-000676, 1518-000677, 1518-000673, 1518-000675, 1518-000674, 1518-000330, 1518-000731, 1518-000346, 1518-000352, 1518-000351, 1518-000350, 1518-000347, 1518-000348, 1518-000546, 1518-000547, 1518-000549, 1518-000550, 1518-000551, 1518-000552, 1518-000555, 1518-000513, 1518-000514, 1518-000097, 1518-000098, 1518-000320, 1518-000321, 1518-000326, 1518-000329, 1518-000250, 1518-000269, 1518-000300, 1518-000746, 1518-000747, 1518-000748, 1518-000749, 1518-000750, 1518-000751, 1518-000150, 1518-000153, 1518-000151, 1518-000154, 1518-000149, 1518-000148, 1518-000147, 1518-000146, and 1518-000152 MANUFACTURED & RECALLED BY Spacelabs Healthcare, Inc., Issaquah, WA QUANTITY 722 units DISTRIBUTION Nationwide and Internationally REASON Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0882-2008 PRODUCT b) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0883-2008 PRODUCT c) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0884-2008 PRODUCT d) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0885-2008 PRODUCT e) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0886-2008 PRODUCT f) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0887-2008 PRODUCT g) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0888-2008 PRODUCT h) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0889-2008 PRODUCT i) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0890-2008 PRODUCT j) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations RECALL NUMBER # Z-0891-2008 CODE a) Lot Numbers: 99513867, 99508829, and 99508830 b) Lot Numbers: 99508645, 99497398, and 99535020 c) Lot Numbers: 99502708, and 99510894 d) Lot Numbers: 99496751 e) Lot Numbers: 99504912, 99509169, and 99534483 f) Lot Numbers: 99504955, 99496794, and 99537348 g) Lot Numbers: 99505290, 99504749, and 99525828 h) Lot Number: 99503850 i) Lot Number: 99504098 j) Lot Number: 99504587 MANUFACTURED & RECALLED BY Argon Medical Devices, Inc., Athens, TX QUANTITY 2,861 devices DISTRIBUTION Nationwide and Internationally REASON Degradation: Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. ---------------------------------------------------------------------------