Agency classClass IIOur severity:High FDA (Devices)·Z-0888-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk

GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.

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: This is an FDA Class II recall involving potential life-threatening injury from detector fall, but the source text indicates no actual injuries have been reported. The hazard is theoretical, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling certain nuclear medicine imaging systems, including the Infinia, VariCam, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 models. These systems are used in healthcare facilities for nuclear medicine imaging.

The systems could have been transported or relocated without proper detector support. When this occurs, excessive load can be applied to the detector mounting mechanisms. This could result in detector fall and life-threatening bodily injury.

The recall affects 36 units distributed worldwide.

The recalled product

Product: GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Nuclear Medicine Imaging
Hazard: detector-fall
mounting-failure
bodily-injury
Affected units: 36

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 (20)

1) 5178728: UDI/DI N/A
System ID YN1200
Serial Number: 16179
System ID YN1650
Serial Number: 17339. 2) H3000WE: UDI/DI N/A
System ID 82426060010
Serial Number Not Available
System ID 82426080021
System ID 82426090035
Serial Number 18605
System ID 82426090037
Serial Number 18604
System ID 82426100057
Serial Number 19191
System ID 82426150036
Serial Number 18624
System ID 82426150038
System ID 82426180015
Serial Number 18611
System ID 082426010021

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 13 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 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 13 products in this recall →

Same manufacturer · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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