Reported Jun 15, 2016 · Terminated
Optima 1.5T MR430s 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?
- Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
- Lot codes and dates
- USOTCSMR
0001272012-001615VEMR0003062012-008605328SMR150012102012-001SMRDEMO010005162012-003801243MR2SM05132013-001970879MR430SM10172011-004509482MR3SM06142013-001641428ONISM10302012-006ARIA430SSM06272013-006207OA430MRSM11262012-007
0SM07082013-012719766SMR0SM5312013-001760725MR1SM08152013-002703805ONIMR4SM11252013-001310665MR0000SM09202013208557MR2SM05212013-004VAD430SM11132012-002856581MR430SM12172012-001303577MR20001212012-001786308MR10012222011-001973586MR0006012011-001SINAI6010007132011-001516482MR4300012042011-001MKMG430S
Missing_SN_GON419427202162012-001805679ONI0012142011-001215DOY430S0006112012-004360786ONIMR0003062012-007212288ONI0010272011-009513636NICMR0003282012-001518453MR20002112012-001803434ONI
141 of 141 codes
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
- Amount recalled
- 101
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.
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.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.