Siemens CIOS ALPHA Fluoroscopic X-Ray System Recalled for Potential Failure
Siemens Medical Solutions is recalling 44 CIOS ALPHA fluoroscopic x-ray systems due to a potential system failure that could interrupt patient procedures.
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 potential system failure that could interrupt patient procedures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 44 units of the CIOS ALPHA image intensified fluoroscopic x-ray system. The recall was initiated because of a potential system failure that may cause an interruption during patient procedures.
The affected units are model #10308191 and were distributed nationwide. The specific serial numbers for the recalled units are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and any necessary corrective actions.
The recalled product
- Product
- CIOS ALPHA; image intensified fluoroscopic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 44
Distribution
Distributed nationwide across the United States.
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