The Recall Desk
HighFDA (Devices)·Z-0954-2015·Announced 2015-01-21

GE Healthcare Proteus XR/a Wall Stand Cable Breakage Recall

GE Healthcare is recalling Proteus XR/a X-ray systems with wall stands due to potential breakage of steel support cables. No injuries have been reported.

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 (falling equipment) where injury has not yet been reported, which aligns with the High severity criteria for medical devices.

Plain-English summary

GE Healthcare is recalling Proteus XR/a X-ray imaging systems equipped with wall stands, specifically model number 600-0301. The recall involves 3,096 units distributed across the United States and numerous international locations.

The recall was initiated because GE Healthcare became aware of a potential safety issue where the two steel cables supporting the bucky device in the wall stand may break. The source text explicitly states that no injuries have been reported in connection with this defect.

Affected units are identified by specific serial numbers and system IDs listed in the recall documentation. Users of these systems should contact GE Healthcare for further instructions on how to address the potential cable breakage issue.

The recalled product

Product
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Manufacturer
GE Healthcare

Distribution

Distributed in 2 states: