NRAC Issue #1634 ADDENDUM June 12, 2007 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. Route To ____________________________________ Status ______________________ PRODUCT LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050 RECALL NUMBER # Z-0925-2007 CODE LP 20 defibrillator serial numbers: DOMESTIC 35246397, 35222145, 35222147, 35222171, 35246407, 35195082, 35202031, 35202041, 35213722, 35213784, 35216799, 35216801, 35219423, 35219450, 35213803, 35213807, 35216785, 35216786, 35216791, 35216793, 35216797, 35219435, 35219444, 35219446, 35219447, 35219448, 35219451, 35219452, 35219463, 35219464, 35219465, 35219467, 35219469, 35222141, 35232801, 35237779, 35237782, 35237784, 35237785, 35237786, 35237788, 35237789, 35237792, 35237793, 35237794, 35237800, 35237802, 35237803, 35239818, 35222169, 35232448, 35232925, 35233140, 35195289, 35213796, 35216787, 35219445, 35216794, 35216795, 35219441, 35219457, 35219459, 35232449, 35213805, 35216784, 35216788, 35219453, 35219454, 35219461, 35150433, 35150435, 35154911, 35158493, 35158499, 35161156, 35161163, 35161242, 35161244, 35161247, 35161249, 35161251, 35161252, 35161253, 35161255, 35161257, 35161258, 35161259, 35161260, 35161262, 35161263, 35161264, 35161267, 35161268, 35161269, 35161270, 35161271, 35161272, 35161273, 35161274, 35161275, 35161276, 35161278, 35161280, 35161281, 35161282, 35161283, 35161286, 35161291, 35166342, 35166344, 35166346, 35166351, 35166354, 35166355, 35166356, 35166357, 35166359, 35166363, 35166365, 35166367, 35166371, 35166372, 35166375, 35166377, 35166381, 35166385, 35166386, 35152846, 35152854, 35150429, 35150431, 35152839, 35152862, 35154877, 35154882, 35154908, 35158482, 35226477, 35226479, 35226482, 35226483, 35226484, 35226487, 35226489, 35226492, 35226493, 35226494, 35226496, 35226498, 35226499, 35226502, 35226515, 35226516, 35233136, 35233149, 35233154, 35233153, 35152851, 35152860, 35047103, 35065639, 35065640, 35065644, 35065649, 35065652, 35065655, 35088936, 35150422, 35150424, 35151610, 35151613, 35151615, 35152861, 35154873, 35154876, 35154883, 35154888, 35152847, 35152853, 35043904, 35084040, 35088934, 35150408, 35150414, 35151616, 35152845, 35154890, 35161171, 35161261, 35161265, 35161288, 35166347, 35166352, 35166353, 35166360, 35166364, 35166366, 35166368, 35166369, 35166370, 35166373, 35166374, 35166376, 35166378, 35166379, 35166380, 35166382, 35172605, 35172611, 35172613, 35226504, 35226510, 35226481, 35233138, 35226500, 35226506, 35226519, 35226520, 35226526, 35244234, 35213806, 35219432, 35219440, 35219442, 35244337, 35226486, 35226497, 35233137, 35245167, 35226518, 35202048, 35219443, 35222137, 35219472, 35222146, 35222153, 35222168, 35219449, 35246388, 35233122, 35233144, 35232447, 35166358, 35222142, 35219456, 35239851, 35158490, 35166361, 35161254, 35226505, 35226509, 35226513, 35226521, 35226524, 35226525, 35233120, 35233123, 35233125, 35233127, 35233129, 35233131, 35233132, 35233134, 35233135, 35233139, 35233141, 35233143, 35233148, 35233150, 35233155, 35233158, 30778465, 31004425, 35233110, 35233142, 35202046, 35213791, 35219458, 35222138, 35222150, 35222156, 35222167, 35222170, 35233116, 35233145, 35233147, 35233152, 35233126, 35213732, 35216789, 35219434, 35232452, 35232810, 35233099, 35233102, 35226378, 35226508, 35233117, 35213790, 35233115, 35233151, 35213801, 35213808, 35213809, 35213810, 35216780, 35219462, 35219466, 35219468, 35219470, 35222139, 35222151, 35222157, 35222163, 35226164, 35226165, 35226166, 35226167, 35226169, 35226170, 35232443, 35232450, 35232806, 35232809, 35232910, 35232915, 35232928, 35232931, 35233090, 35233092, 35233101, 35233103, 35233104, 35233108, 35233109, 35237791, 35065654, 35233133, 35244348, 35245143, 35245162, 35245165, 35246386, 35246391, 35246394, 35246396, 35246399, 35246402, 35246416, 35246420, 35246421, 35246422, 35246423, 35246425, 35246430, 35246431, 35246432, 35246433, 35249248, 35249255, 35222140, 35226490, 35226491, 35233156, 35232442, 35232451, 35219471, 35233128, 35222148, 35222165, 35246393, 35246417, 35246426, 35249256, 35249264, 35250340, 35250349, 35250352, 35250354, 35246406, 35246408, 35187570, 35187729, 35187733, 35187740, 35187745, 35187750, 35187753, 35187754, 35192461, 35192465, 35192467, 35192474, 35192475, 35192488, 35192492, 35192494, 35195062, 35195069, 35195073, 35195074, 35195075, 35195077, 35195085, 35195086, 35195240, 35195243, 35195245, 35195246, 35195247, 35195248, 35195249, 35195250, 35195251, 35195252, 35195253, 35195254, 35195255, 35195256, 35195257, 35195258, 35195259, 35195260, 35195261, 35195262, 35195263, 35195264, 35195265, 35195266, 35195267, 35195269, 35195270, 35195271, 35195272, 35195273, 35195274, 35195276, 35195277, 35195279, 35195280, 35195282, 35195283, 35195284, 35195285, 35195286, 35195287, 35195288, 35200196, 35200197, 35200198, 35202024, 35202025, 35202026, 35202027, 35202032, 35202033, 35202042, 35202043, 35202044, 35202045, 35202047, 35202049, 35202050, 35213720, 35213723, 35213724, 35213726, 35213728, 35213730, 35213781, 35213782, 35213783, 35213785, 35213786, 35213788, 35213789, 35213792, 35213793, 35213797, 35213798, 35213799, 35213800, 35213802, 35216776, 35216777, 35216778, 35216779, 35216781, 35216790, 35216792, 35216796, 35216802, 35216803, 35216807, 35216808, 35216809, 35216811, 35216812, 35216814, 35216815, 35216816, 35219424, 35219425, 35219426, 35219427, 35219428, 35219429, 35219430, 35219431, 35219433, 35219437, 35219438, 35219439, 35232921, 35233114, 35233146, 31339155, 35222160, 35222162, 35213795, 35226480, 35226501, 35226507, 30476108, 35222166, 35232444, 35232804, 30843087, 35154880, 35244327, 35244349, 35244354, 35245145, 35245163, 35245164, 35246384, 35246385, 35246398, 35216800, 35219436, 35233098, 35233106, 35244321 MANUFACTURED & RECALLED BY Medtronic Emergency Response Systems, Inc., Redmond, WA QUANTITY 859 units DISTRIBUTION Nationwide and Internationally REASON White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.) RECALL NUMBER # Z-0913-2007 PRODUCT b) GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) RECALL NUMBER # Z-0914-2007 PRODUCT c) GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System) RECALL NUMBER # Z-0915-2007 CODE a) 65049321 2035762100 4436432100 0002600531A 0002628342A 208227CATH1 208367INNOVA 212305CATH1 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 262255INNOVA2 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 360456XCL4 405604D2100 408559INV1 410337INNOVA6 414447CA1 414649INNOVA2 417347FCV4 501257VALAB1 508856IN21 516562INNOVA6 516562INNOVA7 518243LAB1 518243LAB2 541732CV2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 610776INNOVA21 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 713375U2100 713375UCA 713794LAB1 717217CA10002 717217INN21 717544GECATH2 717544GECATH3 718470EP 727869CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN3 785354HRTEP 804764CATH2 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 815741CA1000 817329BG2100 843724CL1 843724CL2 843724CL3 845365V13 845368CATH1 858554INNOVA2 901765EP 910343EP1 910343EP2 910671CICR 910671INOV21 954987CCL7 954987CCL8 970350CL2 973579LAB1 985898INNOVAB BGRPWSCA01 CM2100 00060VAS02 00159VAS04 00192VAS04 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 35021VAS02 468668XR01 58010VAS01 600042VA03 A004RX01 A4166952 A5125125 A5164510 A5624112 A5807919 B1650215 C5123625 C5123626 DK1066VA02 DZ1006VA01 H17654VAS8 H2077VAS27 HC4355XR06 HU1094VA01 M1334109 M2068110 M2569315 M2844529 M4198195 M4200108 M4211066 MA1004VA02 NO1009VA03 PC0052XR07 PC0052XR08 SA1011VA01 SA1054VA02 SY 1001VA02 cee15663 416480INNOVA 604682INNOVA2 835160018 850060723 910162009 910162010 910162011 910162012 910163011 83016862101656 082416030004 082416040011 082416040012 082416070006 082416100012 082416120008 082416120009 082416130016 082416130019 082416130024 082416200004 082416220010 83016002101586 83016102100795 83016202101036 83016242100936 83016802100516 83016802100866 83016802100916 83016862101656 83016862101916 920169006 YV0054 YV0055 YV0056 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0070 YV0071 YV0072 YV0073 YV0077 YV0080 YX1483; b) 65049331 2035763100 3027443100 5033703100 6106483100 6619483100 7022333100 7028533100 8014793100 8157413100 9734293100 201996LAB1 207351YCL1 207662CL4 208227CATH2 214590PH3100 219326IN31 239513CRLAB1 239939CLA 251633PROV 281420LAB23100 303425CL4 305364P3100 316651INNOVA31 352333CATH1 352333CATH2 361857CATH1 361980INNOVA2 405272SCL2 406543IN3 413582C3100 414649CL3 414649CL4 415925INV1 423844CCL1 479441SP3100 480728LAB2 480821IN2 502587LAB1 508856IN2 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573632CRC2 573882UMC1 610447CL1 610595CL1 610891CL1 616392INNOVA 617732IN9 618241GSI3100 708WESTSUB3100 717782INNOVA31A 718470INNOVA2 760242CATH1 775982CATH2 781340IN2 812450CATH1 812858GWLAB1 812858GWLAB2 814676C1 816478MC1 816943STJIC1 816985NKCI 847362CONCATH4 864255SFCL3 865481CCL2 870864LAB2 901516R3 903UT3100 904276CTH1 907562CATH1 909464IN3 909825VAINNOVA 913345MI1 916781INNOVA1 916781INNOVA1 918494IN31A 940626DCH3100 954987CCL9 970350CL1 970945CL1 405604D3100 405840OIC3100 412623LAB2 414647CL1 541MWHINNOVA 617789IN1 671GMHAINVA 770991CL1 41018VAS01 600098VA01 A5112597 A5125119 A5127281 A5162256 A5333035 B5274834 CS1006VA03 DPM32143 FI1064VA01 FPG86403 FPG93008 GE1005VA01 JO1000VA01 M4016034 M40480151 M4163030 M5480755 NO1005VA05 RU1142VA01 SA1010VA02 dpn88402 850060724 910064007 910162006 910163006 910163009 910163012 910163015 082416010006 082416020004 082416030003 082416040015 082416040018 082416040019 082416080001 082416100006 082416100013 082416110002 082416120007 082416120010 082416130015 082416130017 082416140002 082416150001 082416160003 082416160008 082416160009 082416190001 082416190003 082416190004 082416210003 082416210004 082416210006 082416210008 082416220008 082416220009 082416270002 082416300001 082416310003 082416310006 082449120007 0910064009X 834160003 910064008 920169007 YV0034 YV0043 YV0045 YV0046 YV0047; c) 5135844100 5136864100 314569SJRM12 530888ANG206 713375U4100 804320CATH2B 804764CATH3 812238UN41 812238UN41 813615CL10 843577CL2 972566INNOVA3 80140841 3016094100 3027444100 4134474100 5033704100 5094744100 5417684100 6309784100 7028804100 201541SP1 251435I12 252847PRS3 309672M4100 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 509482HFI 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 678EJCIR1 719560INN41 727791INNOVA 770535N4100 803256SP 804594ANGIO 816943SP1 817433HSW4100 845368RM10 904202SP1 904BSSP 908522SP1 915577SP1 918682IN41 952993INNOVA2 970247INNOVA 972335LIB COR359867 00171VAS01 00490VAS02 10091VAS01 190020RX09 600152VA01 A5605732 BRD0411 IE1100VA01 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 850060707 850060722 082406120016 082416130020 XF0154 XF0155 XF0200 306766INNOVA 519663INNOVA2 MANUFACTURER GE Medical Systems, SCS, Buc Cedex, France RECALLED BY General Electric Med Systems LLC, Waukesha, WI QUANTITY 446 units DISTRIBUTION Nationwide and Internationally REASON Unintended Gantry Movements: GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely. ---------------------------------------------------------------------------