PlainRecalls
FDA Devices Moderate 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

Reported: September 2, 2020 Initiated: July 30, 2020 #Z-2888-2020

Product 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 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).

Details

Units Affected
329 units in total
Distribution
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 329 units in total.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2888-2020.