Recall Z-0134-2009 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
ANGIOSTAR Plus X-Ray System, Model number 6379718.
| Date | Nov 4, 2008 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | Unintended movement of the system table and/or C arm. |
| Root cause | Software design |
| Action | Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision. |
| Quantity | 114 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884912 | ANGIOSTAR Siemens Medical Solutions USA, Inc., Feb 16, 1989 |