Device product
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Z-1281-2016
Product summary
- Event
- Event 73546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1281-2016
Official wording
Reason: Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.
Code information: Model Number: 10308191
Distribution pattern: US Nationwide Distributed in the states of AR, CA, NE and UT
Derived failure modes
-
Unknown
Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.