Reported Jul 10, 2019 · Terminated
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
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 floor -Interventional
- Fluoroscopic X-Ray System Model Number10094135
- Lot codes and dates
- Serial Numbers
63 of 63 codes
135954136032136077136043136190136197136168136143136234136383136242136393136128136147136350136256136314136548136550136557136558137165137119136607137388137231137471137591137245137369137347137329137391137479137425124006138061137461137518137567137582137667137595137656138104138190124116137714124119138012138070138017138058138194138156138214138128138180138188138260
- Serial Numbers
- Amount recalled
- 63
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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