The Recall Desk
HighFDA (Devices)·Z-0894-2025·Announced 2025-01-22

Nuclear medicine system detector mounting safety defect

GE Healthcare is recalling certain nuclear medicine imaging systems that may have improper detector support from transport, creating a risk of detector fall and life-threatening bodily injury.

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 risk-of-harm product (diagnostic nuclear medicine system) where injury has not yet been reported. While the potential hazard—detector fall causing life-threatening injury—is serious, no actual injuries or deaths have occurred. The FDA classification is Class II, and the hazard remains theoretical at this time.

Plain-English summary

GE Healthcare is recalling certain nuclear medicine (NM) and nuclear medicine/computed tomography (NM/CT) imaging systems. Affected models include Discovery NM/CT 670, Discovery NM 630, Brivo NM 615, VariCam, Infinia, and Optima NM/CT 640. Seventeen units are involved and distributed worldwide.

These systems may have been transported or relocated without proper detector support. Improper support can result in excessive load on the detector mounting mechanisms, potentially causing structural failure.

If the detector mounting mechanisms fail due to excessive load, the detector may fall. A falling detector poses a risk of life-threatening bodily injury. Affected healthcare facilities should contact GE Healthcare for further instructions.

The recalled product

Product
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear medicine imaging system
Hazard
  • detector-fall
  • structural-defect
  • impact-injury

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) H3100XF: UDI/DI N/A
  • System ID NT1011
  • Serial Number T2AG12009/ 88227HL4
  • UDI/DI N/A
  • System ID NT2002
  • Serial Number T2AG12011/ 89154HL9
  • System ID NT1009
  • Serial Number T2AG12013/ 90088HL6
  • System ID NT1003
  • Serial Number T2BG11001/ 79573HL2
  • System ID NT1004
  • Serial Number T2AG12003/ 79574HL0
  • System ID NT1005
  • Serial Number 84775HL6
  • System ID NT1020
  • Serial Number T2AG12012/ 89666HL2
  • System ID NT1016
  • Serial Number T2AG13020/ 96237HL3
  • System ID NT0002
  • Serial Number 106491HL4

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category