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.
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 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
- Hazard
Distribution
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