Reported Nov 2, 2022 · Ongoing
ARTIS pheno, Interventional fluoroscopic x-ray system, 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, Interventional fluoroscopic x-ray system, Model No. 10849000
- Lot codes and dates
- UDI-DI04056869046877 Serial No
140 of 140 codes
164140164138164159164331164332164033164287164282164210164183164184164311164312164328164034164391164318164244164306164155164340164189164271164277164173164292164231164095164057164054164055164132164329164072164190164048164025164026164027164338164094164241164326164267164186164068164121164157164019164152164161164013164069164213164073164257164293164263164298164060
- UDI-DI04056869046877 Serial No
- Amount recalled
- 140 US
Where it was sold
- Nationwide
Why it was recalled
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
This product could cause temporary or reversible health problems — stop using it.
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