Recall Z-0483-2010 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis MP, Model number 5904466 angiographic x-ray systems
| Date | Dec 3, 2009 (initiated Oct 26, 2009) |
| Status | Terminated |
| Reason | c-arm may tilt |
| Root cause | Other |
| Action | The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons. |
| Quantity | 70 units |
| Distribution | 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 |