FDA-Device2017-04-26Class II
Artis zee, Angiographic x-ray system
Siemens Medical Solutions USA, Inc
Hazard
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
Sold states
Distributed to: VA, CA, WI
Affected count
3 units distributed in U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis zee, Angiographic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2017Don't want to check this manually?
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