The Recall Desk
HighFDA (Devices)·Z-1959-2020·Announced 2020-05-20

Siemens Cios Spin Mobile X-Ray System Recalled for Electrical Shock Risk

Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

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 46 units of the Cios Spin VA30-mobile X-Ray system (Material # 10308194). The recall is due to a safety hazard where the main cable can be unplugged from the X10 connector on the 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 condition can result in an electrical shock if a user or other persons touch the contact pins, which are accessible when the cable is unplugged.

The affected units were distributed nationwide in the United States. Users should identify their equipment by checking the serial number against the list provided in the recall notice. Siemens is the recalling firm responsible for addressing this issue.

The recalled product

Product
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: 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
46

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.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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