Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagno
FDA device recall Z-1445-2015 · posted 2015-04-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.
- Action taken
- A customer notification, dated March 19, 2015, was distributed to all affected customer via AX018/15/S. Additionally, Siemens has initiated an inspection of Artis Q/ Q zen systems via Update Instruction AX017/15/S.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 139
- Distribution
- Nationwide
- Date initiated
- 2015-03-19
- Date posted
- 2015-04-14
- Date terminated
- 2015-08-06
- 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 |