Z-1295-2019 Class II Terminated
FDA device recall Z-1295-2019 was initiated by Siemens Medical Solutions USA, Inc on March 22, 2019 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated May 12, 2020). Affected quantity: 2 US.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- March 22, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 US
Product 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
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution in the states of NC, MA
Code Information
Cios Alpha system with SW VA30