Recall Z-0118-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
CIOS ALPHA; image intensified fluoroscopic x-ray system
| Date | Aug 17, 2015 |
| Status | Terminated |
| Reason | patient procedure interruption due to a potential system failure |
| Root cause | Device Design |
| Action | Customer Safety Advisory Notice XP038/15/S, dated August 17, 2015, was sent to direct accounts to alert them to the issue and provide work-around instructions to avoid potential risks. |
| Quantity | 44 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132094 | CIOS ALPHA Siemens Medi Cal Solutions, Inc., Mar 11, 2014 |