Siemens Recalls 37 Cios Alpha Mobile X-ray Systems for Freezing Defect
Siemens is recalling 37 Cios Alpha mobile X-ray systems because they may freeze during procedures. The recall is classified as Class II.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a device malfunction (freezing) during clinical procedures where injury has not been explicitly reported in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 37 units of the Cios Alpha mobile X-ray system. The recall is classified as Class II by the U.S. Food and Drug Administration.
The Cios Alpha is a mobile X-ray system designed to provide imaging of anatomical structures during clinical applications, including interventional fluoroscopic, gastro-intestinal, and emergency room procedures. The affected units may freeze during a procedure under certain circumstances.
The recall involves 37 units distributed nationwide. Affected units have Model Number 10308191 and specific serial numbers listed in the recall documentation. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the affected devices.
The recalled product
- Product
- Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 37
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)
- Model Number of device 10308191
Distribution
Distributed nationwide across the United States.
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