FDA-Device2017-03-22Class II
Artis Q and Q.Zen fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
Hazard
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Sold states
Distributed Nationwide
Affected count
2,158 units distributed in US and 6,139 units worldwide
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis Q and Q.Zen fluoroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2017Don't want to check this manually?
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