Reported Mar 25, 2020 · Terminated
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
10848355 | Artis Q.zen Ceiling |
10848354 | Artis Q.zen Floor |
10848353 | Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. |
- Lot codes and dates
- Serial Numbers***Added 3/30/2020*** 123031 123022
123225105120123026105028111005111122111124111125123236111002123053123050123008123035123003123032123208123209123231123206123207123240105025111121123219111115111116111117111118111119111120123229123205123224123232123233123234123027111107123055123056105017123010123046111000111106123052111123111128123200123015123016105112
- Serial Numbers
- Amount recalled
- 1452 worldwide (638 US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
A software issue could potentially cause the stand and table movements to be blocked.
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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