Siemens Cios Alpha Mobile X-Ray Systems Recalled for Missing Insulating Foil
Siemens is recalling one Cios Alpha VA20/VA30 mobile X-ray system because the DAP chamber may be missing an insulating foil.
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 missing insulating foil presents a risk of harm (electrical shock or equipment malfunction) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one Cios Alpha VA20/VA30 mobile X-ray system. The recall was initiated because the Dose Area Product (DAP) chamber may be missing an insulating foil.
The affected unit is identified by Material # 10308191 and Serial # 13161. The device was distributed in Illinois and Nebraska.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the missing component.
The recalled product
- Product
- Cios Alpha VA20/ VA30 mobile X-Ray systems
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Mobile X-Ray
- Affected units
- 1
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)
- Material # 10308191 Serial # 13161
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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