The Recall Desk
HighFDA (Devices)·Z-2291-2014·Announced 2014-08-27

GE Healthcare Recalls Discovery XR656P/N Wall Stand Systems Due to Hook Failure

GE Healthcare is recalling 334 Discovery XR656P/N wall stand systems because nylon hooks supporting the detector may fail, causing the detector to fall.

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 heavy medical equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 334 units of the Discovery XR656P/N digital radiographic system (model numbers 5374989/5397837). The recall involves a potential safety issue with the nylon hooks that support the FlashPad detector on the wall stand systems.

The recall was initiated after reported incidents of detector falls. The source text explicitly states that no injuries have been reported as a result of these incidents. The affected units are distributed in 31 US states and 33 countries outside the US.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Patients and staff should be aware that the detector may fall from the wall stand, posing a risk of injury or equipment damage. GE Healthcare is managing the recall to address the defect in the nylon hooks.

The recalled product

Product
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Radiographic Equipment
Hazard

Distribution

Distributed in 31 states:

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