Axiom Artis Systems operating with A100 Generator
FDA device recall Z-1237-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by repeated release of the x-ray footswitch or button. To remedy the issue described above, a revised cabling has been installed in all potentially affected syste
- Action taken
- The recalling firm issued a Customer Safety Advisory to affected customers via Update Instructions AX006/10/S. The letter informs customers of the potential issues and provides additional information on the implemented resolutions. For additional information, please contact the firm at 888-826-9702.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 1373 units
- Distribution
- The product was shipped to medical facilities nationwide.
- Date initiated
- 2010-03-04
- Date posted
- 2010-04-05
- Date terminated
- 2012-07-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |