The Recall Desk
HighFDA (Devices)·Z-0782-2020·Announced 2020-01-15

Siemens Cios Alpha Mobile X-Ray System Recalled for C-Arm Holder Crack

Siemens Medical Solutions is recalling Cios Alpha mobile X-ray systems because a crack in the C-arm holder could compromise stability and lead to injury.

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 risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential injury without confirmed cases.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Cios Alpha mobile X-ray systems, Model Number 10308191. The recall involves 190 units, with an updated total of 202 units as of January 20, 2020. These systems were distributed nationwide in the United States.

The recall was initiated after a routine inspection discovered a crack on the C-arm holder. If the C-arm holder is cracked, the stability of the C-arm may be compromised, potentially leading to deformations. In very unlikely cases, an extreme impact to the C-arm, such as a heavy collision with a wall or table, could cause the C-arm to detach, which could potentially result in injury to patients and staff.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to proceed with the recall and repair of the affected units.

The recalled product

Product
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

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