Recall Z-1534-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Q, Interventional Fluroscopic x-ray system
| Date | Mar 19, 2017 (initiated Feb 22, 2017) |
| Status | Terminated |
| Reason | In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator. |
| Root cause | Other |
| Action | A Customer Safety Advisory Notice (CSAN) was mailed on 02/22/2017 to customers affected by the issue on 02/22/2017 to inform them of the corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the impact on system operation and the potential risk to patients. It also informed users of the actions being taken and how they will be implemented. |
| Quantity | 264 distributed worldwide (112 in the U.S.) |
| Distribution | Distributed throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123529 | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Feb 26, 2013 |