Recall Z-0347-03 ยท IZI System, X-Ray, Angiographic
Siemens Medical Systems Inc
Axiom Artis System, X-ray, Angiographic
| Date | Dec 18, 2002 (initiated Aug 5, 2002) |
| Status | Terminated |
| Reason | Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked. |
| Root cause | Other |
| Action | 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. |
| Quantity | 134 |
| Distribution | The device was distributed to Hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp., Mar 30, 2001 |