FDA-Device2021-05-05Class II
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Medical Solutions USA, Inc
Hazard
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Sold states
Nationwide
Affected count
772 units U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2021Don't want to check this manually?
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