The Recall Desk
HighFDA (Devices)·Z-1248-2015·Announced 2015-03-18

GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Cable Breakage Risk

GE Healthcare is recalling Proteus XR/a X-ray systems because a steel cable supporting the bucky device may break. A falling bucky could injure a patient or operator.

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 where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare is recalling 192 units of the Proteus XR/a with wall stand (model number 2260354). These devices are intended for generating radiographic images of human anatomy in general diagnostic procedures and are not intended for mammographic applications.

The recall is due to a potential breakage of the steel cable that supports the bucky device in certain wall stands. If the bucky falls while the system is in use, it could result in an injury to a patient or operator.

The affected units were distributed worldwide, including nationwide in the United States and in 21 other countries. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.

The recalled product

Product
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Manufacturer
GE Healthcare
Category
Medical Device — Diagnostic Imaging
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

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