FDA Recall
Terminated
Artis Q and Q.Zen fluoroscopic x-ray system
Recall: Z-1466-2017
·
Initiated February 27, 2017
Recall
- Recall Number
- Z-1466-2017
- Event Number
- 76615
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 27, 2017
- Terminated
- January 14, 2019
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
Artis Q and Q.Zen fluoroscopic x-ray system
Reason
A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
Action
A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.
Distribution
Distributed Nationwide
Quantity
2,158 units distributed in US and 6,139 units worldwide