FDA-Device2013-11-20Class II
Artis zee systems x-ray, angiographic system
Siemens Medical Solutions USA, Inc
Hazard
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Sold states
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Affected count
17
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Artis zee systems x-ray, angiographic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0172-2014Don't want to check this manually?
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