Recall Z-0484-2010 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis dMP, Model number 7555365 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 | 32 unit |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS Siemens Medical Solutions USA, Inc., Jun 6, 2002 |