Reported Feb 21, 2018 · Terminated
Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one…
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 oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
- Lot codes and dates
Serial # 82044821058207082054820408203882065 82108820108203982109 82102 82066
- Amount recalled
- 207 worldwide (13 distributed in US)
Where it was sold
Why it was recalled
The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
This product could cause temporary or reversible health problems — stop using it.
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