The Recall Desk
HighFDA (Devices)·Z-2127-2020·Announced 2020-06-03

Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk

Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.

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, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 58 units of the Cios Alpha Image-Intensified Fluoroscopic X-Ray System, specifically model numbers VA20-10308191 and VA30-10308194. These mobile X-ray systems are designed to provide imaging of anatomical structures during clinical applications.

The recall is due to a safety defect where unplugging the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage of up to 67.6 V DC at the connector. This condition can result in an electrical shock if a user or other persons touch the contact pins of the X10 connector.

The affected units were distributed nationwide to facilities in Arkansas, Arizona, California, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Puerto Rico. Affected serial numbers are listed in the official recall documentation. Users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve this issue.

The recalled product

Product
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 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.
Affected units
58

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc

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