Reported Dec 21, 2016 · Terminated
SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by…
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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Lot codes and dates
- Serial Numbers
104 of 104 codes
651279579873739832776621965491654539573896357656157372666467648607386065712653046543765614658569630573296738318340373840647099633573673656399500365501963517377896028963168352096288663969623896352963249633665480963129576873777959557388383399737839622696303960476560973791738877307196266957017436883537
- Serial Numbers
- Amount recalled
- 104 systems
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
- Nationwide
Why it was recalled
Software update that provides software and firmware bug-fixes to improve system performance
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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