Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.
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 (electrical shock) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 16 units of the Cios Alpha VA30-mobile X-Ray system (Material # 11105200) distributed nationwide in the United States. The recall involves specific serial numbers: 40057, 40047, 40048, 40107, 40108, 40111, 40120, 40126, 40134, 40135, 40032, 40104, 40075, 40102, 40124, and 40070.
The recall is due to a safety hazard where the main cable can be unplugged from the X10 connector on the main unit (c-arm) at any time during a clinical session. If the system displays the error message Err 16305 / 80, unplugging the main cable can cause an unsafe electrical voltage of 125 V DC at the X10 connector. This can result in an electrical shock if a user or other persons touch the accessible contact pins when the cable is unplugged.
Healthcare facilities and users should identify if they possess any of the affected serial numbers. Siemens is the recalling firm and is responsible for addressing the defect. Users should follow instructions provided by Siemens or the FDA regarding the safe handling of these devices to prevent electrical shock.
The recalled product
- Product
- Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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