The Recall Desk
HighFDA (Devices)·Z-2122-2015·Announced 2015-07-29

GE Healthcare Precision RXi Digital System Monitor Suspension Recall

GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk 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 is classified as FDA Class II and involves a risk of physical injury (falling monitor) to patients or operators, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare is recalling the Precision RXi Digital system due to a reported incident where a monitor fell from its suspension. The recall also affects single and dual LCD monitor suspensions used on the Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, and Precision MPi fluoroscopic imaging systems.

The hazard is that a falling monitor could result in an injury to a patient or operator. The recall covers 788 units, with 701 distributed in the US and 87 outside the US. Distribution was worldwide, including the US, Australia, Canada, Germany, and other listed countries.

Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify a particular action such as stopping use, but the recall is active for the identified serial numbers.

The recalled product

Product
GE Healthcare Precision RXi Digital 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 →