Siemens Recalls Cios Alpha X-Ray Systems Due to Electrical Shock Risk
Siemens is recalling four Cios Alpha mobile X-ray systems because a defective part could increase the risk of electrical shock for service personnel during maintenance.
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 3/5 (High).
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 electrical shock (risk-of-harm product) where no injuries have been reported, and the hazard is conditional on ignoring safety steps, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling four units of the Cios Alpha image-intensified fluoroscope x-ray system. The recall is due to a defective part found in the production line that could increase the risk of electrical shock for service personnel working inside the device during system maintenance.
The risk of electrical shock is present only when a service technician ignores several precautionary steps listed in the service manual during device maintenance. The affected units were distributed in the states of Arkansas, California, Nebraska, and Utah.
Service personnel should follow the precautionary actions listed in the service manual to mitigate the risk. Siemens is the recalling firm for these units.
The recalled product
- Product
- CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 10308191
Distribution
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