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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 20
Distribution
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.
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