Recall Z-0578-2007 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis MP, Angiographic x-ray system, model number 5904466
| Date | Mar 8, 2007 (initiated Jan 31, 2007) |
| Status | Terminated |
| Reason | C-arm gantry could rapidly descend without command during use. |
| Root cause | Other |
| Action | In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary. |
| Quantity | 62 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 |