Reported Nov 27, 2019 · Terminated
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
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 go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
- Lot codes and dates
- software syngo CT VA20A_SP2 and active Guide&GO license
- Amount recalled
- 14 US
Where it was sold
Why it was recalled
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
This product could cause temporary or reversible health problems — stop using it.
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