Reported Sep 7, 2022 · Ongoing
Artis pheno- Model No. 10849000
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 pheno- Model No. 10849000
- Lot codes and dates
- UDI-DI04056869046877 Serial Numbers***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795
69 of 69 codes
164766164140164138164287164740164210164183164184164776164312164071164034164391164763164306164735164277164095164072164771164743164048164741164241164186164069164213164728164263164060164113164398164366164279164774164074164084164086164098164153164330164389164394164772164718164163164297164778164333164377164397164300164105164227164022164250164739164703164187164211
- UDI-DI04056869046877 Serial Numbers
- 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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