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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recall see related information
Date Posted April 10, 2013
Recall Status1 Terminated on January 27, 2014
Recall Number Z-1078-2013
Recall Event ID 64398
510(K)Number K022960  K991841  K052434 
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
843724INF
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
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
Process control
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
Distribution Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
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
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