FDA Enforcement
Class II
Terminated
Cios Spin, 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
Recall: Z-2888-2020
·
Reported September 2, 2020
Enforcement
- Recall Number
- Z-2888-2020
- Event ID
- 86166
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 2, 2020
- Initiation Date
- July 30, 2020
- Classification Date
- August 26, 2020
- Termination Date
- May 20, 2021
- Address
- 40 Liberty Blvd, N/A, Malvern, PA, 19355, United States
Description
Cios Spin, 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
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).
Code Info
Cios Spin (VA30)- 10308194
Distribution
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Quantity
329 units in total