High FDA (Devices)·Z-0891-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk

GE Healthcare is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.

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: This is an FDA Class II recall involving risk-of-harm from potential detector falls described in the source as capable of causing life-threatening injury. No incidents have been reported, placing this in the 'risk-of-harm products without reported injury' category per the severity rubric.

Plain-English summary

GE Healthcare is recalling 859 units of certain nuclear medicine imaging systems, including the Discovery NM/CT 670, Discovery NM 630, Brivo NM 615, Infinia, VariCam/VG/VH, and Optima NM/CT 640 models. These systems were distributed worldwide.

The recalled systems may have been transported or relocated without proper detector support. When systems are moved without adequate support, excessive load can be applied to the detector mounting mechanisms, potentially causing the detector to fall. A detector fall poses a risk of life-threatening bodily injury to patients or staff in proximity to the equipment.

No injuries or deaths have been reported related to this issue. The FDA has classified this as a Class II recall. The recalling manufacturer is GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING.

The recalled product

Product: GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Nuclear Medicine Imaging System
Hazard: detector-fall
trauma-injury
Affected units: 859

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) 5376204-70-54-2: UDI/DI N/A
System ID NT1030
Serial Number T27G16017/ 133897HL9
UDI/DI N/A
System ID NT4004
Serial Number T27G15008/ 128542HL8
System ID NT4008
Serial Number T27G16019/ 134674HL1
System ID NT4007
Serial Number T27G16018/ 134286HL4
System ID NT4009
Serial Number T27G16016/ 133646HL0
System ID NT1021
Serial Number T27G1700031/ 147750HL4
System ID NT4010
Serial Number T27G16020/ 134675HL8
System ID NT4012
Serial Number T27G1700032/ 148489HL8
System ID NT4001
Serial Number T27G15002/ 122818HL8

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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