Recall Z-1824-2017
Siemens Medical Solutions USA, Inc · initiated March 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Artis zee, Angiographic x-ray system
Codes / lots: Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744
Reason for recall
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-determined cause: Nonconforming Material/Component
Action taken
Siemens mailed a Customer Safety Advisory Notice (CSAN) AX017/17/S to affected customers on 03/28/2017 to inform them of the corrective action that will be performed to prevent a possible hazard to persons and equipment. The notice also explained the underlying issue, the impact on system operation, potential risk to patients and actions they are taking to correct the issue.
Details
- Recall number
- Z-1824-2017
- Initiated
- March 28, 2017
- Posted by FDA
- March 30, 2017
- Terminated
- August 7, 2017
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 3 units distributed in U.S.
- Distribution
- Distributed to: VA, CA, WI
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA