Recall Z-0848-04 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis System
| Date | Jul 20, 2004 (initiated May 28, 2003) |
| Status | Terminated |
| Reason | patient images misidentified |
| Root cause | Other |
| Action | The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem. |
| Quantity | 46 units |
| Distribution | The products were shipped to medical facilities 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 |