Reported Sep 7, 2022 · Ongoing
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
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- Model No. 11327600 Artis icono floor- Model No. 11327700
- Lot codes and dates
- Artis icono biplane- Model No. 11327600
- UDI-DI04056869063317 Serial Numbers***Updated 9/23/22*** 180466 180465 180464 180047 180463 ***Updated 1/9/23***
77 of 77 codes
180062180054180019180421180444180034180072180446180367180438180382180060180428180369180370180371180372180080180301180305180067180399180442180040180379180386180360180333180352180407180433180412180400180397180432180316180447180363180429180084180418180334180018180376180354180046180434180357180358180361180362180081180423180411180414180381180021180443180309180356
Artis icono floor- Model No. 11327700180470180534180468180472180467180469180066180082
- UDI-DI04056869149325 Serial Numbers***Updated 1/9/23*** 170402
170319170391170392170397170026170388170343170367170368170360170349170361170383170322170385170386170025170384170346170051170358170389170357170365170387170390170393170394170378170396170053170364
- Amount recalled
- 1,389 (590 US; 799 OUS) (Total)
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
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
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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