Recall Z-1449-04 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
| Date | Sep 14, 2004 (initiated Aug 10, 2004) |
| Status | Terminated |
| Reason | Opacification Function of device may incorrectly merge images |
| Root cause | Other |
| Action | The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem. |
| Quantity | 37 units |
| Distribution | The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA. |
| 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 |