FDA-Device2017-03-22Class II

Artis Zee and Zeego 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
2158 units distributed in US and 6,139 worldwide
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis Zee and Zeego fluoroscopic x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2017

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