Reported Jul 10, 2019 · Terminated
Siemens 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 · 19355-1418
Is this the product you have?
- Siemens Artis zee ceiling -Interventional
- Fluoroscopic X-Ray System Model Number10094137
- Lot codes and dates
- Serial Numbers
276 of 276 codes
147208146637146395146728146942146697146663146731146945146774146784146866147186146867146692146869146759146776146775146797146871146801146857146803146886146758146806146851146929147157146971146919146969146973146925147695146948146964147046146861147123146883147216147866146888146955147214146921147931147100146928146946147030146983146899147089146975146963146986146960
- Serial Numbers
- Amount recalled
- 276
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
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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