Reported May 5, 2021 · Ongoing
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
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 zee ceiling-interventional
- Fluoroscopic X-Ray System Model Number10094137
- Lot codes and dates
- Serial Numbers
772 of 772 codes
125000125001125002125003125004125005125006125008125009125010125011125013125015125016125017125019125021125022125023125024125100125105125106125108125109125112125113125115125116125117125118125119125201125202125204125205125208125209125210125211125212125213125214125216125219125222125223125226125227125228125229125230125231125232125233125235125238125239125240125241
- Serial Numbers
- Amount recalled
- 772 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
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This 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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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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