Recall Z-1824-2017 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis zee, Angiographic x-ray system
| Date | Mar 30, 2017 (initiated Mar 28, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 3 units distributed in U.S. |
| Distribution | Distributed to: VA, CA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |