Agency classClass IIOur severity:High FDA (Devices)·Z-2121-2015·Announced 2015-07-29

GE Healthcare Precision RXi 23A/32A Analog System Monitor Suspension Recall

GE Healthcare is recalling Precision RXi 23A/32A Analog Systems because a monitor suspension failure could cause a monitor to fall and injure a patient or operator.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 where a falling monitor could injure a patient or operator, but the source text does not report that an injury actually occurred, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare is recalling the Precision RXi 23A/32A Analog 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 Precision 500D Classical R & F systems, Precision RXi Digital systems, and Precision MPi fluoroscopic imaging systems.

The hazard is that a falling monitor could result in injury to a patient or operator. The recall covers 788 units, with 701 distributed in the United States (including GU and DC) and 87 distributed outside the US in countries including Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan, Turkey, United Kingdom, Venezuela, and Yemen.

Affected units are identified by specific manufacturing lot or serial numbers, including 00000001386MC2, 00000002109MC7, 00000001010MC8, 00000001337MC5, 00000002212MC9, 00000001720MC2, 00000001098MC3, 00000001454MC8, 00000001082MC7, 00000001266MC6, 00000001656MC8, and 00000003661MC6. Users should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product: GE Healthcare Precision RXi 23A/32A Analog System
Manufacturer: GE Healthcare
Category: Medical Device — Fluoroscopy System
Hazard: falling-object
impact-injury

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 →

Same manufacturer · GE Healthcare

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Same hazard · falling object