Reported Dec 1, 2021 · Terminated
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and…
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?
- Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and
- interventional procedure Model Number10094141
- Lot codes and dates
- Serial Numbers156011 156014
- Amount recalled
- 2 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
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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