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Recall Observatory FDA recall evidence

Device product

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

Z-2888-2020

July 30, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 86166
Status
Terminated
Classification
Class II
Quantity
329 units in total
Official record key
device-enforcement:Z-2888-2020

Official wording

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 information: Cios Spin (VA30)- 10308194

Distribution pattern: US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).