Z-2887-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- July 30, 2020
- Termination Date
- May 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 329 units in total
Product Description
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Reason for Recall
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Distribution Pattern
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Code Information
Cios Alpha (VA20)- 10308191 Cios Alpha (VA30)- 11105200