Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems develo
FDA device recall Z-0601-2017 · posted 2016-11-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
- Action taken
- Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 4,657 systems (worldwide)
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2016-11-01
- Date posted
- 2016-11-17
- Date terminated
- 2017-06-21
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529) | Siemens Medical Solutions USA, Inc. | 2013-02-26 |