Reported Feb 12, 2014 · Terminated
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed,…
Siemens Medical Solutions USA, Inc.
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: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
- Lot codes and dates
models 809802777407691043060310590000
- with multiple serial numbers
147 of 147 codes
647896449266767666496406766182653646467364419665186624364368640816039866929663276614666188663556646764860643427357973813641796649864172664336657266768647906619364270665036501365014648216433764734650366645566451669286540365597647706696466924640826615166911655766701764481646946684473366644306530264624
- Amount recalled
- 147
Where it was sold
- Nationwide
Why it was recalled
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
This product could cause temporary or reversible health problems — stop using it.
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