The Recall Desk
HighFDA (Devices)·Z-2120-2015·Announced 2015-07-29

GE Healthcare Precision 500D Monitor Suspension Recall

GE Healthcare is recalling Precision 500D and related fluoroscopic systems because monitor suspensions may fail, posing a risk of injury to patients or operators.

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 potential injury without confirmed harm.

Plain-English summary

GE Healthcare is recalling the Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system, and Precision MPi fluoroscopic imaging systems. The recall involves the single and dual LCD monitor suspensions used on these devices.

The recall was initiated after a reported incident where a monitor fell from its suspension. The source notes that a fall of a monitor could result in an injury to a patient or operator.

The recall affects 788 units, with 701 distributed in the US and 87 outside the US. Distribution was worldwide, including the US nationwide (including GU and DC) and 22 other countries. Users should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product
GE Healthcare Precision 500D Classical R & F system.
Manufacturer
GE Healthcare

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by GE Healthcare 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 4 products in this recall →