Reported Jul 16, 2025 · Ongoing
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Ge Medical Systems Israel, Functional Imaging
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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 4, Hayozma St · Tirat Carmel, N/A · N/A
Is this the product you have?
- Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- Lot codes and dates
- Serial NumbersInfinia I193S08002; Infinia I Hawkeye 1
161431614916179163151633516353168261733917799184201844218604186051861118624186271862818629186371863918641186441864518647186481864918650186511865218653186551865618657
16433; Infinia II84 of 84 codes
150061500715013160011600316004160051600616007160081600916011160121601316015160161601916021160221602416026160271602816030160331603716038160391604316044160481604916050160511605216054160571605916060160631606416065160701607316074160791608116082160831608416087160911609916107161091611416123161261612716132
16477/16479; INFINIA II HAWKEYE 4880 of 880 codes
160451609416115161351617016190161911619416196161981620616207162081620916211162121621316214162181622016221162231622416227162281622916234162351623916244162461625016259162621626316271162791628516296163031630416305163101631216313163181631916322163231632416326163341633616355163561636516370163711637216376
822 of 822 codes
161061613016199162001620116202162041620516215162221622616232162421624816251162521625416256162581626416265162671627016273162771627816280162821628716288162921629416299163021630916317163251632716328163291633016331163331633816341163471634816349163501635216357163601636116362163731637416383163861638816390
- Serial NumbersInfinia I
- Amount recalled
- 1822
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
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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