Reported Nov 19, 2014 · Terminated
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4,…
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 Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye
- and Infinia II VC Hawkeye 4) ModelsH3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine
- Systems Infinia devices Product UsageThe intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications
- Lot codes and dates
- ARHINFI
357 of 357 codes
15012919684INF116089319356INF16168801562JVH0216074519749INFINIA216061824260400331607682426040030160858242631001516158DK1029NM0516067FI1023MN0216068FI1153MN0116141A515296416056NO1088MN091615200053NUC0616001906776INF16005615768SCNM116015717782INF16018907562NM116033318681INFINIA16036920738INF16043210921NM116045941637INF16051507345INF116054630801INF16065860350INIF16071763UNTYINFI16075937328INF216083973625INFINIA16084518828INF16088908522INFINIA16098203325INF2
LGMCINF16411812522INF16412352333INF16413228436INF16415773665INF216418773665INF116421
FHEINF231 of 231 codes
16422812485INF16425607737INF16426610770INFINIA16429828696INFINIA116437415222IN116441801357INF116442601936INF116443305835INF16454443481INF16456804594INF116457845783ORA0116464210705NM116465615284INF116466843724INF216470630856INF16474417256INF16475504873INF216475504380INF16477502259INF16479843431IN16489732292INFINIA16491301877INF16494479463INF16497248898INF16499615342INF116528225381INF16534319768INF216539214879INF16541951696INF116542630275INF
SLGHINF81 of 81 codes
16912441236INFINIA16918601288INF116920954735INF216923309344SMNUC16929513867INF16935901765INFRM816937217544NUC116963209385IN16964561650INF116965718948INF16969404265INF16971704316INFI16973972969INF16983310319INF116984225658INF16988816836CIIN16991309655INF116993843689INF17001304637INF17006985785INF17007330721INFINIA117010765456INF17012318681INFINIA217016918307INF117026817346INF17027920451INF17036662772INFRM117040732840INFINIA17043805489INF117045662772INFRM2
GILESINF363 of 363 codes
17117863679INF117119630312INF17129225647INF17133256494NM117134330344INFINIA117141207795INFINIA17142337943INF17144727942INF17146228818INF17150480324INF17152502624INF17166931403NM117168843674IN117177248849INF117182256543INF117184931381NM217186404686INF17188843832INF17189518562INF17201618544INF17205CRAVENINF317211918494INF217212580931INF117216316858GI17218815756INF17221203797INF17223CRAVENINF217224662423INFINIA17228COR37327317229607756INF2
CFRHINF67 of 67 codes
17893985649INF217894681342INF217897302629INF17899843606INF117900256327NUC17901704355INF217902240566INF17904281274INF17908701774NM17909804225INF117910972394INF17913704355INF117941606878INF217944901287INF117947706278INF17948828262INFINIA17957262687INF217958843777IN1179626502IN217964307332INFINIA17965704863INF117968239NCHINF117969708660INF17970248471INF17971443481BINF17972828766INFINIA17975757312INF217976860344INF17980615349NM217981843777IN2
BRMCINF215 of 215 codes
17993616267INFINIA17996843782INF17997302733INF17998480882INF218002718240INF218006281251SLVINF18015774442INF18017816392RINF18027713794INF318029843692IN118030954978INF118048832522INF18051920849INF18052832522INF218058435893INF18059478454INF18063269223VABCINF18064281348INF18065757312INF118066847990INF118067814643INF18088225NOINF18097610327INFINIA18104885INFI218106325235NUC18114951672INF118115704225INF118117405742INF118119319272INF18120973831INFINIA
VASINF1,273 of 1,273 codes
18469435251INF218475865717INF18480228523HWK218481843777IN318511918505INF118548908522INFINIA218560610459INF18336386362INF100000000091BH9DZ1534NM0100000000056BH2DZ1035NM0400000000059BH6DZ1035NM031638191026405816527910265053165319102650551668591026406216807910262196169959102650591705191026407917077910263190175339102622341811891026412916592AH5689NU0117911AH3403NU0116198030018NU0516583080004NU1316805130083NU1316829190073NU0116882080053NU0217281100029NU0117385110093NU07
JOHNINF735 of 735 codes
16818503561INF16824918494INF116835937374INF116845626898INF116855678474INF16879262767INF16883707963IN16884619229INF16892714953INFINIA16894414489INF16895806GRACENM16931435750INF216952801501INF116981925370IN16459440329INF16364415750IN116652719333IH16771906337INF161939102631431621091026217016217910266050162688309483185516274910266053163939102631591643591026316116439910263166164719102650501662291026406016362AH5293NM0416440AH5249NM04
VCWESTINF17916864SPAHK117922419383NM117923540689INF117926541296HK417932540689INF217933304623INF117935304623INF217937937268INF117940
CSNMINFINIA105 of 105 codes
17954801357INF217960312996INF17967435781INF117973916782IN117977864SPAHK217979301295INF117985206223INF217986916537IN17987916782IN217995559353IN18000215728INFINIAJ18001972596INF18003713794INF218005301295INF218007215707INFINIA18021701857NM18024913588INF218026480882INF118028920738INF118047301714INF18057817255INF18060212989INF118082816404INF118090802388INF18093210358IHE18094607763INF18098732321IH418105214370INF18107920738INF218113757395INF1
PRINCEINF18302330363INFINIA218307712279INF18308209223IN18314515247INF118316508457INF18325361595SKI118326512LRMCNM18327608263INF318329608324INF18330718883INF118337541754HK418338515247INF218343412653INF118348814877INFINIA18353703391INF218359412372INF118373715623INF18380469764INF18400
170 of 170 codes
18412918599INF118413817920INF18418262569INF18422602406INF118425620232INF18430706651INF18435770400INF18459608775INF318460916733IN18465602406INF318470479553INF18472814534INF118474703504HAWK118482570621INF218489540332INF318490812265KDINF18502313473INF18508262928INF18513715423INF18515408315IN218516979241INF18524606759INF18531530533IN18571270745INF116924304264INF16809DZ1338NM0100000056555HL6DZ1279NM01173981577INFINIA182362962725INFINIA18444NM18444
- Amount recalled
- 2479
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
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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