High FDA (Devices)·Z-0893-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Detector Fall Risk

GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.

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 FDA Class II recall involves a serious risk of life-threatening bodily injury from potential detector falls, but no injuries or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injuries score at the High severity level.

Plain-English summary

GE Healthcare has recalled certain Discovery NM/CT 670 PRO nuclear medicine imaging systems and related models used in medical facilities for diagnostic imaging procedures. A total of 283 units have been identified in this recall, distributed worldwide.

The systems could have been transported or relocated during manufacturing or installation without proper detector support. This can result in excessive load being applied to the detector mounting mechanisms, potentially causing the detector to fall. A falling detector poses a risk of life-threatening bodily injury to personnel working with or in proximity to the equipment.

Healthcare facilities using these systems should immediately verify whether their equipment is among the recalled units by checking the system model and serial numbers listed in the recall notice. Any facility with an affected system should stop using the equipment and contact GE Healthcare for further instructions and support options.

The recalled product

Product: GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Nuclear Medicine Imaging
Hazard: detector-fall
mechanical-failure
Affected units: 283

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 NT4011
Serial Number 131640HL5
UDI/DI N/A
System ID NT1023
Serial Number 154472HL5
System ID NT4003
Serial Number 128062HL7
System ID NT4005
Serial Number 128536HL0
System ID NT1022
Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A
System ID 83131625480
Serial Number T27G15012/131277HL6
System ID 83119512125
Serial Number T2AG14038/0
System ID 83151204341
Serial Number T27G1600025/0
System ID 83153611901
Serial Number T27G1700030/147506HL0

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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