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
Recall
- Recall Number
- Z-1295-2019
- Event Number
- 82613
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 22, 2019
- Terminated
- May 12, 2020
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
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
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
Siemens issued Customer Safety Advisory Letter dated 3/22/19 advising of problem, health risk and action to take: recommends to avoid overwriting the organ programs, as this can lead to frequent operations. Siemens is distributing this letter and the addendum to the user manual to all potentially affected users Contact our service organization for any additional questions at 1-800-888-7436.
US Nationwide Distribution in the states of NC, MA
2 US