The Recall Desk
SevereFDA (Devices)·Z-2128-2020·Announced 2020-06-03

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

Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of electrical shock, which is a significant injury hazard. Per the rubric, significant injury reports or risks warrant a score of 4 (Severe).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 20 units of the Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Number VA30-10308194. 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 24 states and Puerto Rico. Specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The company is the recalling firm and is responsible for addressing the defect.

The recalled product

Product
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Affected units
20

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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