FDANovember 25, 2019device

Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

What to do

FDA enforcement status: Terminated

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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