Reported Apr 27, 2022 · Ongoing
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single…
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?
- Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures
- Model11327600
- Lot codes and dates
- S/N
94 of 94 codes
180062180054180019180065180056180057180041180421180317180034180072180349180367180382180060180337180070180048180083180369180370180371180372180345180315180343180080180301180305180067180330180040180379180386180360180333180029180352180336180407180412180400180397180316180068180363180084180418180334180018180350180376180354180046180047180335180085180035180339180357
- UDI04056869063317
- S/N
- Amount recalled
- 94 U.S.
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
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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