The Recall Desk
HighFDA (Devices)·Z-1281-2016·Announced 2016-04-06

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.

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 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: int
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

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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