Reported Jun 15, 2016 · Terminated
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
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?
- MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
- Lot codes and dates
- Mfg Lot or Serial # System IDSPRUCEEXT
0001072011-001708216MR30001082010-001AIC2020001272010-001RADNETMR16560002032011-001407333EXTMR0003072010-001702254LVRMR0003242009-001JCI1780004012010-001201487ONI0005152009-001ZPR21850005262010-001CALPAC0030006012008-001MHMH1620006082010-001
172 of 172 codes
0006182010-001205930MR30007142009-001POA1870009142010-00161500009172009-001RADNETMR16410010182010-001305CMI20011292010-001513636EXTMR0012052010-001713791BONIMR0012162008-001HCH1700012182008-001916734EXMR0007152011-001MREQUINE3SM12062013-002718518MR430S0008152010-00109102720740008142012-001AP4502MR010004082010-001MR040820100005072010-001MR050720100007082010-001MR070820100007092010-001MR070920100011242009-001MR112420090012142009-001MR121420090012152009-001MR121520090003292011-001EG1252MR020004192011-001EG1524MR01SM02042013-001607849MR01SM04292013-001PC0127MR04SM05062013-001533398MR01SM06092014-002419793MR01SM06182013-001PC4318MR03SM07182014-005115530MR01SM08152013-001123701MR01SM09132012-003PC9982MR01
- Mfg Lot or Serial # System ID
- Amount recalled
- 97
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
This product could cause temporary or reversible health problems — stop using it.
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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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