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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Recall
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Date Posted April 10, 2013
Recall Status1 Terminated on January 27, 2014
Recall Number Z-1078-2013
Recall Event ID 64398
Premarket Notification
510(K) Numbers
K022960  K052434  K991841 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Code Information System ID (As required) 787764INFINIA-1 SA2146NM01 TN1366NM01 SA1001MN01 PK1031NM01 PK1032NM01 PK1180NM08 PK1184NM01 PK1307NM01 PK1336NM01 MA1439NM01 LB1122NM02 KW1013NM01 KW1013NM02 KW1018MN06 KW1018MN08 EG1124MN02 323268INF1 630312INF 630545INF 630856INF 630275INF 330344INFINIA1 518262INF1 518262INF2 518262INF3 724226INF1 ARHINFI 610770INFINIA 502893INF 443481BINF 443481INF 443481INF2 661949NUC1 804594INF1 480323INFRM1 607737INF 404265INF 330363INFINIA 920451INF 920907INF 305682INF1 602588INF 904821INF3 904821NM1 904821NM2 615284INF1 904627INF2 904321INF1 904202INF1 501202INF 662244INFINIA 225381INF 972394INF 727863INF1 713359INF1 419483NUC2 406731INF1 228436INF 865977INF 804281INF1 804225INF1 941VRMCINF 248471INF 203384INF 269657SHINF 718240INF2 718240INF1 BCHINF1 513454INF1 843402INF2 843606INF1 609730INF1 GILESINF 217554CINF 843674IN1 843674IN2 843674IN3 704225INF1 704355INF1 704355INF2 704863INF1 770382INM 973877INFINIA 859313INF 423625INFINIA 859498INF1 937440INF2 606878INF1 606878INF2 512528NM1 305325INF 615342INF1 816380CASSINF 816392RINF 816836CIIN SLGHINF 207795INFINIA 518562INF 757312INF1 757312INF2 410337INF3 973831INFINIA 708684INF1 302733INF 318681INFINIA2 281599INF1 805489INF1 352344INF 256327NUC 704487INFINIA1 718948INF 843782INF 931403NM1 256429INF1 CFRHINF 727521INF 904276INF1 702255INF 210617NM1 847990INF1 814533INF2 814534INF 607756INF 607756INF2 740623INFINIA 319272INF CRAVENINF2 CRAVENINF3 CRAVENINF1 618544INF 402449INF 337436INF 318798INFINIA 203797INF 304637INF 205750INF 205759INF 256341NRM1 760778INF1 702369NM 760241INF1 850883ENM 904542NM 502624INF 727581INF 630786INF 786308INF1 786308INF2 214324INF 919684INF3 318330INF1 843412INF 504454INF 303837INF 330721INFINIA1 330721INFINIA2 502350INF 904819INF1 928214INF FHEINF 954735INF2 813788INF1 225647INF 318327INF1 318388INF1 601288INF1 865373INF 865429INFINIA 240566INF 256494NM1 316858GI 662256INFINIA 561650INF1 843692IN1 319768INF 319768INF2 770229INF 979532INF1 706278INF 828586INFINIA 262670INF2 978521INF 517543INF 727942INF 256386HKNM2 906293INF 618942INF 305835INF 847480INF 843689INF 605353NM 435251INF1 801357INF1 701364INF 703858INF 815432INFINIA 814643INF 773947INF 570398INF 502955INF 859268INF1 502259INF 732321INFINIA 954265INF1 561744INF 305227INF1 305227INF2 262656INF2 513867INF 441236INFINIA 704739INFI 281348INF 307332INFINIA 225658INF 772LMCNM2 901287INF1 LGMCINF 304831LNM1 951672INF1 805737INF1 805370INF1 304623INF1 304623INF2 609835INFINIA 707822INFINIA 409938INF 828696INFINIA1 252436INF1 415925INF 925779IN 740383INF1 843431IN 402461INF 931381NM2 843777IN1 843777IN2 814333INFINIA1 814333INFINIA2 478633INFINIA 732840INFINIA 580931INF1 727843INF1 815756INF 609267INF 713242INF2 713242INF3 432685DNUC 812522INF MVINFNM2 913345INF1 209385IN 419455INF1 701774NM 281274INF 402354INF 832522INF 832522INF2 614478INF1 615349NM1 615349NM2 860344INF 662772INFRM1 662772INFRM2 662772INFRM4 405610MINF1 617313INF1 603924INF 973971INFINIA 212241INF2 801465INF1 302629INF NASHNM2 601443INF1 518773INF 239NCHINF1 281897INF1 212608INF1 COR373273 COR373282 617243INFINIA 405307INF1 352333INF 225NOINF 985230INF 770219INF 770535INF1 210757NM1 215537INFINIA 985646INF 479751INF 954978INF1 203852INF 704316INFI 516IPKINF1 352596INF1 708660INF 734467INF 734671INF 228818INF 885INFI1 885INFI2 478454INF 801479INF 801479INF2 ORMCINFINIA2 OBNM1 913541INF1 908522INFINIA2 908522INFINIA3 417256INF 661PMCNUC1 845987INFINIA 435658INF 423493PINF 803329INFIN1 PITTINF5 571231INF1 571231INF2 610327INFINIA 303839INF 815432INF 248849INF1 248849INF2 903785INF 505863INF 816348INF1 804254INF 618395INF 601936INF1 732530INFINIA 256543INF1 325235NUC 843402INF 843724INF2 773995INF 828286INFINIA 920849INF 918494INF2 918494INF3 918502INF1 501776INF 518271INF 310832INF1 502868INF1 480882INF2 435893INF 951696INF1 818907INF1 805543INF1 479524INF 605333INF2 985649INF1 985649INF2 856363INFINIA 404466INF 229259INF 229333ICINF1 229333ICINF2 912691SCNC 918294INF1 610869INF 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LT4000MN01 0850260077 0850260088 0850260089 0850260106 0850260107 0850260112 0850260079 0850260060 0850260061 0850260087 0850260076 0850260090 0850260105 0850260110 0850260068 0850260121 0850260065 0850260103 0850260081 0850260115 0850260123 0850260120 0850260093 0850260094 0850260063 0850260069 0850260070 0850260067 0850260073 0850260124 0850260091 0850260095 0850260104 0850260114 0850260083 0850260092 0850260113 0850260066 0850260080 0850260082 0850260099 0850260064 0850260100 YN1562 YN1566 YN1573 YN1581 YN1584 YN1571 YN1559 YN1579 YN1570 YN1551 YN1588 YN1575 YN1543 YN1586 YN4930 YN1567 YN1552 YN1561 YN8003 YN1560 YN1545 YN1554 YN4949 YN8001 YN1583 YN1556 YN1546 YN1558 YN1574 YN1544 YN1568 YN1569 YN1557 YN4922 YN1542 YN1563 YN4923 YN5000 YN1549 YN1564 YN1565 YN1547 YN4929 YN1541 YN1582 YN1540 YN1539 YN1550 YN4990 YN1577 YN1548 YN1587 YN1589 YN1578 YN1553 YN1196 YN1580 YN1555 YN1572 YN1585 YN4920 YN4918 YN4919 YN4924 YN4925 YN4927 YN4934 YN4921 YN4931 A5279302 A5181662 A5634003 B5142302 B5142304 A5315551 A5113627 A5178021 B5395703 C5120912 A5924402 A5109665 A5109666 A5216824 A5162248 A5352208 D5111607 A58080111 A58080134 A5111240 A5215935 A5129026 A5267107 A51043155 A51043187 A51152163 A51152164 B5365422 083026602101669 083026802101686 083026801003210 083026602101279 083026002002289 IL1069NM06 IL1068NM05 IL1018NM07 IE1006MN04 HU1099NM01 HR4103NM01 05452NUC03 00271NUC04 00624NUC01 00624NUC03 00116NUC01 00186NUC02 IE1564NM03 00289NUC02 00203NUC03 00231NUC09 00165NUC04 IE1510MN09 00669NUC01 00169NUC07 10497NUC01 00440NUC11 00440NUC07 70027NUC03 00171NUC04 77624NUC01 77624NUC03 V1471114 V2943415 V7406615 V7405209 M4159227 M4159228 M4018536 M4163763 M4018099 B5483443 A4169304 M8572211 M1400803 M4024095 A4194407 X105967813 M2269829 V2728105 M4167153 M218669001 M4211068 M5172527 X61014001 X100611101 M4023087 M9886832 M1279727 M4480232 M1804913 M4135141 B4182004 M4234232 M4234235 M4479619 M44827146 E4858901 M4144332 P4211482 R4211480 M9162716 X59007307 M7411106 X2034002 X151957601 S4160059 M4040544 M4215553 X4211026 FE443890 DE539254 UEW19003 UEW19005 MPX46902 DEN01721 DEN01727 UPW00402 GPQ19105 ME051533 UE720407 MPX82204 MPX47106 EG1826MN01 DK1023NM05 HC7475NU03 HC0842NU01 CHAM01NU01 UC7655NU03 HC0507NU03 HC1249NU01 HC1249NU02 493519NU01 PC1818NU03 PC8118NU01 HC1819NU01 CC3899NU01 HC3442NU01 HC0892NU04 HC4387NU02 2583615INF 2928217inf 262010NU01 475290NU01 529150NU04 905683IN1 613969INFINIA 819537INFINIA 819537INFINIA2 416928INFINIA 709737INFINIA 204837IN1 416813INFINIA 416444INFINIA1 905855INFINIA2 905855INFINIA3 905472INFINIA 905832INFINIA 613727INFIN 514934AINFINIA 416756INFINIA2 905773INFINIA1 905845INFINIA1 705759INFINIA2 403777INFINIA3 306655INFINIA2 306655INFINIA4 905895INFINIA1 905895INFINIA2 905522INFINIA 905522INFINIA2 705674INFINIA 519965INFINIA 905848INFINIA 250727INFINIA1 082426040034 082426040035 082426270006 082426190016 082426140020 082426140021 082426120006 082426120017 082426040037 082426110007 082426140017 082426150022 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Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare sent an " IMPORTANT PRODUCT INFORMATION" letter dated March 6, 2012. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology/Cardiology. The letter described the Issue, instructions, Affected Product Details, and Product Correction. For questions contact your local GE Healthcare Service Representative or call the GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other Countries 262-896-2890.
Quantity in Commerce 2180
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA