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Siemens Medical Solutions USA, INC recalls Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one
Recalled February 21, 2018 · FDA recall Z-0614-2018 · Siemens Medical Solutions USA
Hazard
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 · FDA Class II
Units
207 worldwide (13 distributed in US)
Sold at
US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
Description
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
Product
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
Manufacturer(s)
Siemens Medical Solutions USA, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →