Reported Apr 17, 2013 · Terminated
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- System ID (As required)ARHINFI
787764INFINIA-1SA2146NM01TN1366NM01SA1001MN01PK1031NM01PK1032NM01PK1180NM08PK1184NM01PK1307NM01PK1336NM01MA1439NM01LB1122NM02KW1013NM01KW1013NM02KW1018MN06KW1018MN08EG1124MN02323268INF1630312INF630545INF630856INF630275INF330344INFINIA1518262INF1518262INF2518262INF3724226INF1
GILESINF610770INFINIA502893INF443481BINF443481INF443481INF2661949NUC1804594INF1480323INFRM1607737INF404265INF330363INFINIA920451INF920907INF305682INF1602588INF904821INF3904821NM1904821NM2615284INF1904627INF2904321INF1904202INF1501202INF662244INFINIA225381INF972394INF727863INF1713359INF1419483NUC2406731INF1228436INF865977INF804281INF1804225INF1941VRMCINF248471INF203384INF269657SHINF718240INF2718240INF1BCHINF1513454INF1843402INF2843606INF1609730INF1
SLGHINF217554CINF843674IN1843674IN2843674IN3704225INF1704355INF1704355INF2704863INF1770382INM973877INFINIA859313INF423625INFINIA859498INF1937440INF2606878INF1606878INF2512528NM1305325INF615342INF1816380CASSINF816392RINF816836CIIN
CFRHINF207795INFINIA518562INF757312INF1757312INF2410337INF3973831INFINIA708684INF1302733INF318681INFINIA2281599INF1805489INF1352344INF256327NUC704487INFINIA1718948INF843782INF931403NM1256429INF1
FHEINF727521INF904276INF1702255INF210617NM1847990INF1814533INF2814534INF607756INF607756INF2740623INFINIA319272INFCRAVENINF2CRAVENINF3CRAVENINF1618544INF402449INF337436INF318798INFINIA203797INF304637INF205750INF205759INF256341NRM1760778INF1702369NM760241INF1850883ENM904542NM502624INF727581INF630786INF786308INF1786308INF2214324INF919684INF3318330INF1843412INF504454INF303837INF330721INFINIA1330721INFINIA2502350INF904819INF1928214INF
LGMCINF954735INF2813788INF1225647INF318327INF1318388INF1601288INF1865373INF865429INFINIA240566INF256494NM1316858GI662256INFINIA561650INF1843692IN1319768INF319768INF2770229INF979532INF1706278INF828586INFINIA262670INF2978521INF517543INF727942INF256386HKNM2906293INF618942INF305835INF847480INF843689INF605353NM435251INF1801357INF1701364INF703858INF815432INFINIA814643INF773947INF570398INF502955INF859268INF1502259INF732321INFINIA954265INF1561744INF305227INF1305227INF2262656INF2513867INF441236INFINIA704739INFI281348INF307332INFINIA225658INF772LMCNM2901287INF1
VASINF1,077 of 1,077 codes
304831LNM1951672INF1805737INF1805370INF1304623INF1304623INF2609835INFINIA707822INFINIA409938INF828696INFINIA1252436INF1415925INF925779IN740383INF1843431IN402461INF931381NM2843777IN1843777IN2814333INFINIA1814333INFINIA2478633INFINIA732840INFINIA580931INF1727843INF1815756INF609267INF713242INF2713242INF3432685DNUC812522INFMVINFNM2913345INF1209385IN419455INF1701774NM281274INF402354INF832522INF832522INF2614478INF1615349NM1615349NM2860344INF662772INFRM1662772INFRM2662772INFRM4405610MINF1617313INF1603924INF973971INFINIA212241INF2801465INF1302629INFNASHNM2601443INF1518773INF239NCHINF1281897INF1212608INF1
JOHNINF237 of 237 codes
804323INF1775423INF1361572NM1281338INF1915521HNM1503435INF845794INFINIA6525011INF1925370IN361985SNM406238INF812426INF757889INF1719333IH207255INFINIA678474INF703698INF1626573INF1818409INF1806GRACENM937374INF1706494HNM801501INF1801314INF1801IMCINF1925785IN410550INF704660HAWK262741INFLGMCINF2435750INF2510400IN713242INF1713ACCINF1228865HWK262767INF916983INFN1530225IN937390INF1218333INF1701234INF626898INF1727461VG212241INF3402559INF1760873NUC504838INFH315592INF704384INH1915577NM1706291HINM956971NM1802775INFINIA503561INF757388INF2913676SMIM508674INFINIA608791INF918494INF1707963IN
VCWESTINF116 of 116 codes
408851IN415838IN4082IN262656INF1262741INF2801299INF1801408INF2610402INFINIA2718150INF16502IN1540741INF1NM156449801387INF1478633INFINIA2972596INF337981INF713456INF410822HK1610278INFINIA916453IN608756INF901516NINFHK254519NMINF541296HK4718405INF1231935INF615769NM1COR359309COR369576770751INF817255INF662377INFINIA937438INF901516UINFHK718334INF1718334INF2718963INF1WH718616INF507OLMINF1ORMCINFINIA1337289INF270688INF404605INF803329HAWK802388INF570621INF425261INF541387INF248465INF360PSPHINF1703689INF4919784INF1401444INF801RHINF732937INFINIA540689INF1540689INF2503561HK4281420INF505609INFINIA
529 of 529 codes
757395INF1206223INF2301714INF863680INF1513298INF1513298INF2623207INF262687INF414325INF570552INF586416INF203688INF085326004008532600250853260036085326003208532600300853260035085326002906051NUC0408562600300856260032C001NU06C001NU10N001NU02N001NU06AC001NU18RU3314NM01RU1018NM01RU3508NM01PER03520PER08009787653INFINIA2PL1143NM06PL1692NM01600042NM06092026908709202690920920269093NO1068MN09APL0232ZTP0133EMM013108342600122750751INFNMCR-178492766055INFHE436INF2753220085026010808502601110850260096085026011908502601170850260098YN4237YN4225YN4248YN4245YN4243YN4288
- System ID (As required)
- Amount recalled
- 2180
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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