The Recall Desk
HighFDA (Devices)·Z-1752-2019·Announced 2019-06-19

GE Healthcare Recalls Proteus XR/a Radiographic Systems Due to Monitor Fall Risk

GE Healthcare is recalling 825 Proteus XR/a radiographic systems because a monitor fell off its wall mount due to product aging.

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 monitor) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 825 units of the Proteus XR/a radiographic system. The recall involves 38 units in the United States and 787 units outside the US. The systems were distributed nationwide in the US and in numerous countries worldwide.

The recall was initiated after a reported incident where a Distar CRT monitor fell off the monitor wall mount. The incident was attributed to product aging. The affected product codes are 651789WDR1 and PL1005RX03.

The source text does not specify the exact actions consumers or healthcare providers should take, nor does it provide a specific date for the recall. Users of these systems should contact GE Healthcare for further instructions regarding the monitor mount issue.

The recalled product

Product
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and m
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Radiographic System
Hazard

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)

  • 651789WDR1 and PL1005RX03

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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