Artis zee, Angiographic x-ray system
FDA device recall Z-1824-2017 · posted 2017-03-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 3 units distributed in U.S.
- Distribution
- Distributed to: VA, CA, WI
- Date initiated
- 2017-03-28
- Date posted
- 2017-03-30
- Date terminated
- 2017-08-07
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |