Reported Nov 23, 2016 · Terminated
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to…
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, Computed
- tomography system Product UsageSOMATOM Definition Flash systems are 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
760 of 760 codes
730646478964492651276446464471653806663265852646686423965364645807347673339642786475673059648006441265288646456472573421645086533965346647146583164123642466569065752646587331266858654916661164465650766445465762644856444664673663196441966518659686650666171662437354464368647366562064081641176454965175
- Serial Numbers
- Amount recalled
- 762 systems distrtibuted in U.S.
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
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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