The Recall Desk
HighFDA (Devices)·Z-0900-2025·Announced 2025-01-22

GE Healthcare nuclear medicine imaging systems recalled for detector fall risk

GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening 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 Class II FDA recall of a high-risk device where improper handling could result in life-threatening injury, but no illnesses or injuries have been reported to date. The recall addresses a documented hazard pathway from improper transport or relocation to serious bodily harm.

Plain-English summary

GE Healthcare is recalling certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 nuclear medicine imaging systems. The recall affects 30 units distributed worldwide.

These systems can present a serious hazard if transported or relocated without proper detector support. When handled improperly, excessive load may be applied to the detector mounting mechanisms, potentially causing detector failure and fall. A falling detector creates a risk of life-threatening bodily injury to nearby personnel.

Facilities that have received these systems should verify that they are properly supported during any transport or relocation. Affected customers should contact GE Healthcare for detailed instructions on proper handling, relocation procedures, or corrective actions.

The recalled product

Product
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine Imaging System
Hazard
  • detector-fall
  • mechanical-failure

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) ASM000085: UDI/DI N/A
  • System ID NM10569
  • Serial Number 10569
  • UDI/DI N/A
  • System ID NM10570
  • Serial Number 10570
  • System ID YN0845
  • Serial Number 10242
  • System ID YN0498
  • Serial Number 1092
  • System ID YN0440
  • Serial Number 1003
  • System ID 979764VGH1
  • Serial Number 77521848
  • System ID NM10225
  • Serial Number 10225. 2) ASM001092: UDI/DI N/A
  • System ID 310231VGH1
  • Serial Number 10539
  • System ID 207795VH
  • Serial Number 10571

Distribution

Distribution scope not specified by the agency.

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