NRAC Issue #1639 ADDENDUM July 17, 2007 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular) RECALL NUMBER # Z-1043-2007 PRODUCT b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System) RECALL NUMBER # Z-1044-2007 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 417269SCLA 417347FCV4 501257VALAB1 508856IN21 516562INNOVA6 516562INNOVA7 518243LAB1 518243LAB2 541732CV2 570476INNOVA21 573256MHC 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 600151VA01 A004RX01 A4166952 A5125125 A5164510 A5624112 A5807919 B1650215 C5123625 C5123626 DK1066VA02 DZ1006VA01 H17654VAS8 H2077VAS27 HC4355XR06 HU1094VA01 HU1205VA01 M1334109 M2068110 M2569315 M2844529 M4198195 M4200108 M4211066 MA1004VA02 NO1009VA03 PC0052XR07 PC0052XR08 SA1011VA01 SA1054VA02 SY1001VA02 cee15663 416480INNOVA 604682INNOVA1 604875AINNOVA1 604875AINNOVA2 835160018 850060723 910162009 910162010 910162011 910162012 910163011 83016862101656 082416030004 082416040012 082416070006 082416100012 082416120008 082416120009 082416130016 082416130019 082416130024 082416200004 082416220010 83016002101586 83016102100795 83016202101036 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 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 PL1082VA01 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 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 MANUFACTURER GE Medical Systems, SCS, Buc Cedex, France RECALLED BY General Electric Med Systems LLC, Waukesha, WI QUANTITY 373 units DISTRIBUTION Nationwide and Internationally REASON Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) AxSYM Troponin-I ADV Reagent Pack; list 02J44-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1023-2007 PRODUCT b) AxSYM Toxo IgG Reagent Pack; list 03B22-22; 100 test pack; an in vitro diagnostic RECALL NUMBER # Z-1024-2007 PRODUCT c) AxSYM Rubella IgG Reagent Pack; list 03B23-20; 100 test pack; an in vitro diagnostic RECALL NUMBER # Z-1025-2007 PRODUCT d) AxSYM CA 125 Reagent Pack; list 03B41-22; 100 test pack; an in vitro diagnostic RECALL NUMBER # Z-1026-2007 PRODUCT e) AxSYM CA 15-3 Reagent Pack; list 03B42-22; 100 test pack; an in vitro diagnostic RECALL NUMBER # Z-1027-2007 PRODUCT f) AxSYM AUSAB Reagent Pack; list 03C74-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1028-2007 PRODUCT g) AxSYM Folate Reagent Pack; list 03C81-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1029-2007 PRODUCT h) AxSYM Myoglobin Reagent Pack; list 03E43-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1030-2007 PRODUCT i) AxSYM Toxo IgM Reagent Pack; list 04B25-22; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1031-2007 PRODUCT j) AxSYM Rubella IgM Reagent Pack; list 04B46-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1032-2007 PRODUCT k) AxSYM CMV IgG Reagent Pack; list 04B47-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1033-2007 PRODUCT l) AxSYM Anti-HCV Reagent Pack; list 05C36-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1034-2007 PRODUCT m) AxSYM CMV IgM Reagent Pack; list 05C78-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1035-2007 PRODUCT n) AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1036-2007 PRODUCT o) AxSYM CORE 2.0 Reagent Pack; list 08B88-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1037-2007 PRODUCT p) AxSYM CORE-M 2.0 Reagent Pack; list 08B89-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1038-2007 PRODUCT q) AxSYM HAVAB 2.0 Reagent Pack; list 08D21-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1039-2007 PRODUCT r) AxSYM HBsAg Reagent Pack; list 09B01-20; 100 test pack; in-vitro diagnostic RECALL NUMBER # Z-1040-2007 CODE a) Lots 49238M200, 49238M201, 49238M202, 49238M203, 51411M100, 51411M102; b) Lot 49109M100; c) Lot 49146M100; d) Lot 49467M200; e) Lots 48100M200, 50118M100, 50152M200; f) Lots 45304M200, 45304M201; g) Lots 49488M200, 50483M200; h) Lot 48718M100; i) Lot 49114M100; j) Lot 50061M100; k) Lot 48069M200; l) Lots 49454M200, 50006M100, 51129M100, 51130M100; m) Lots 48839M100, 50450M100, 51252M100; n) Lot 48466M100, 50410M200; o) Lot 49633M100; p) Lot 50589M100; q) Lots 48132M200, 48139M200, 51069M100; r) Lots 49492M200, 50261M100, 50672M100 MANUFACTURED & RECALLED BY Abbott Laboratories MPG, Abbott Park, IL QUANTITY 28,061 packs DISTRIBUTION Nationwide and Internationally REASON Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxSYM instrument. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ THE FOLLOWING IS AN UPDATE TO THE RECALL LISTED IN ISSUE #1628, DATED MAY 1, 2007, PAGE 1. PRODUCT a) Contak Renewal 3 (model H170, H175) Contak Renewal 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D) RECALL NUMBER # Z-1047-2007 PRODUCT b) Contak Renewal; 3 RF (model H210, H215), Contak Renewal; 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D) RECALL NUMBER # Z-1049-2007 PRODUCT c) Vitality AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies RECALL NUMBER # Z-1052-2007 PRODUCT d) Vitality 2 (model T165, T175), Vitality DS (model T125, T135), Vitality EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing) RECALL NUMBER # 1053-2007 PRODUCT e) Vitality DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing) RECALL NUMBER # Z-1054-2007 PRODUCT f) VITALITY 2 EL DR/VR (model T167, T177). Contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias. RECALL NUMBER # Z-1055-2007 CODES Since there are more than 73,000 units involved in this product recall, please contact Rhoda at National Recall Alert Center with lot numbers you are inquiring about. You may reach Rhoda toll free at 1-800-RECALL NOW (1-800-672-2669) or via email - rhoda@recallalert.org. MANUFACTURER Boston Scientific Corporation CRM Ireland, Clomel, Tipperary, Ireland RECALLED BY Boston Scientific CRM Corp., Saint Paul, MN QUANTITY 73,008 units DISTRIBUTION Nationwide and Internationally REASON Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months. ---------------------------------------------------------------------------