Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error
Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a hardware error in the X-ray generator. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 329 units of the Cios Spin and Cios Alpha mobile X-ray systems. These devices are designed to provide X-ray imaging of anatomical structures during clinical applications.
The recall is being conducted because Siemens identified a hardware error that affects these systems following a previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU). The source text does not specify the exact nature of the hardware failure or any reported injuries or illnesses associated with the defect.
The affected units were distributed in the United States to the states of North Carolina, Nebraska, Illinois, Texas, Ohio, Florida, Wisconsin, Minnesota, Maryland, South Carolina, California, New York, Virginia, Oklahoma, and Arizona. Healthcare facilities should contact Siemens for further instructions on how to address this hardware error.
The recalled product
- 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
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 329
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Cios Spin (VA30)- 10308194
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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