The Recall Desk
HighFDA (Devices)·Z-0890-2025·Announced 2025-01-22

Nuclear Medicine Systems at Risk of Detector Fall During Transport

Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.

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 a Class II FDA recall with potential for life-threatening injury from detector fall. However, no illnesses or injuries have been reported, and the hazard is theoretical based on what could occur during improper transport. Per the rubric, recalls with no reported harm and purely theoretical risk cap at 'High' (3), even with life-threatening consequences.

Plain-English summary

GE Healthcare has recalled certain nuclear medicine imaging systems, including Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 models. The recall affects 704 units distributed worldwide. These systems may have been transported or relocated without proper detector support during shipment or facility relocation.

During transport without adequate support, excessive load can be applied to the detector mounting mechanisms. This can potentially result in the detector falling, creating a risk of life-threatening bodily injury to operators and facility staff.

Facilities with affected systems should contact GE Healthcare to verify that their equipment was properly supported during any recent transport or relocation. Units that may have been improperly transported should be inspected before being returned to clinical service.

The recalled product

Product
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine Imaging System
Hazard
  • detector-fall
  • structural-defect
  • injury-risk

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) 5376204-30-2: UDI/DI N/A
  • System ID NT3058
  • Serial Number T2BG1600023/ 146187HL0
  • UDI/DI N/A
  • System ID NT3061
  • Serial Number T2BG1600029/ 147600HL1
  • System ID NT3111
  • Serial Number 147243HL0
  • System ID NT3072
  • Serial Number 151822HL4
  • System ID NT3081
  • Serial Number T2BG1700045/ 155928HL5
  • System ID NT3080
  • Serial Number T2BG1700042/ 155272HL8
  • System ID NT3098
  • Serial Number T2BG1700051/ 158839HL1
  • System ID NT3088
  • Serial Number T2BG1700048/ 157050HL6
  • System ID NT3073
  • Serial Number T2BG1700040/ 150067HL7

Distribution

Distribution scope not specified by the agency.

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