Reported Jan 21, 2015 · Terminated
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
- Lot codes and dates
- Mfg Lot or Serial # System ID
00000437461CN7519646REVO100000437837CN8M232225400000438342CN882821009600000437028CN4REV00100000438864CN1900010CT0600000439199CN1260010CT1900000439068CN8AE1477CT0100000437787CN5786596WKRIVO00000438503CN5206598REV100000438951CN6309655REVCT00000439029CN0801662REV100000439160CN3212241REVCT00000439367CN4415476MCT3
- Mfg Lot or Serial # System ID
- Amount recalled
- 13 (7 US, 6 OUS)
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
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
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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