Axiom Artis System, X-ray, Angiographic
FDA device recall Z-0347-03 · posted 2002-12-18 · Terminated
Recall details
- Recalling firm
- Siemens Medical Systems Inc
- Reason for recall
- Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
- Action taken
- A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 134
- Distribution
- The device was distributed to Hospitals nationwide.
- Date initiated
- 2002-08-05
- Date posted
- 2002-12-18
- Date terminated
- 2004-10-25
- Location
- Iselin, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |