Reported Jul 13, 2022 · Ongoing
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
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, Interventional Fluoroscopic X-Ray System, Model No. 11327600
- Lot codes and dates
- UDI-DI04056869063317
- Serial Numbers
88 of 88 codes
180062180054180019180065180056180057180041180317180034180072180349180367180382180060180399180337180070180048180083180369180370180371180372180345180315180343180080180301180305180067180330180040180379180386180360180333180029180352180336180407180400180397180316180068180363180084180334180018180350180376180354180046180047180335180085180035180339180357180358180361
- Amount recalled
- 195 worldwide, 88 US
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
Why it was recalled
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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