ARTIS Q, Interventional Fluroscopic x-ray system
FDA device recall Z-1534-2017 · posted 2017-03-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 264 distributed worldwide (112 in the U.S.)
- Distribution
- Distributed throughout the United States.
- Date initiated
- 2017-02-22
- Date posted
- 2017-03-19
- Date terminated
- 2017-10-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529) | Siemens Medical Solutions USA, Inc. | 2013-02-26 |