FDA Recall
Terminated
CIOS ALPHA; image intensified fluoroscopic x-ray system
Recall: Z-0118-2016
·
Initiated August 17, 2015
Recall
- Recall Number
- Z-0118-2016
- Event Number
- 72138
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 17, 2015
- Terminated
- December 5, 2016
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
CIOS ALPHA; image intensified fluoroscopic x-ray system
Reason
patient procedure interruption due to a potential system failure
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.
Distribution
Nationwide Distribution.
Quantity
44