Device product
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 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-1295-2019
Product summary
- Event
- Event 82613
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 US
- Official record key
device-enforcement:Z-1295-2019
Official wording
Reason: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Code information: Cios Alpha system with SW VA30
Distribution pattern: US Nationwide Distribution in the states of NC, MA
Derived failure modes
-
Unknown
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists