Reported May 5, 2021 · Terminated
Artis systems - Product Usage
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
Is this the product you have?
Artis systems - Product Usage
27 of 27 products
| Model / number | Product as published |
|---|---|
05904433 | AXIOM Artis FC |
05904441 | AXIOM Artis FA |
05904466 | AXIOM Artis MP |
05904649 | AXIOM Artis BC |
05904656 | AXIOM Artis BA |
05917054 | AXIOM Artis dBC Mag. Nav. |
07007755 | AXIOM Artis TA |
07008605 | AXIOM Artis dTA |
07412807 | AXIOM Artis dFC |
07413078 | AXIOM Artis dTC |
07555357 | AXIOM Artis dBA |
07555365 | AXIOM Artis dMP |
07555373 | AXIOM Artis dFA |
07727717 | AXIOM Artis dFC Mag. Nav. |
07728350 | AXIOM Artis TC |
07728392 | AXIOM Artis dBC |
10094135 | Artis zee floor |
10094137 | Artis zee ceiling |
10094139 | Artis zee MP |
10094141 | Artis zee biplane |
- Lot codes and dates
- All serial numbers
- Amount recalled
- 3,320 units U.S.
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
Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
This product could cause temporary or reversible health problems — stop using it.
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