The Recall Desk
HighFDA (Devices)·Z-1953-2019·Announced 2019-07-17

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.

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 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
Hazard
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

Distributed in 2 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · electrical shock

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