Reported Mar 31, 2021 · Terminated
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and…
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
Is this the product you have?
- Interventional Fluoroscopic
- X-Ray System - Product Usagedeveloped for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
- Lot codes and dates
- ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
- Amount recalled
- 29 systems
Where it was sold
Why it was recalled
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
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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