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Siemens Medical Solutions USA, Inc recalls Artis zee, Angiographic x-ray system
Recalled April 26, 2017 · FDA recall Z-1824-2017 · Siemens Medical Solutions USA
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. · FDA Class II
Units
3 units distributed in U.S.
Sold at
Distributed to: VA, CA, WI
Description
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.
Product
Artis zee, Angiographic x-ray system
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →