The Recall Desk
HighFDA (Devices)·Z-0898-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk

GE Healthcare's Infinia nuclear medicine systems may have been transported without proper detector support, risking detector falls and life-threatening injury. The recall affects 93 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 is an FDA Class II recall where the hazard (detector fall from improper transport support) could result in life-threatening injury, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

GE Healthcare has issued a recall for certain Infinia I Hawkeye 1 nuclear medicine systems (models H3000WN, H3000YM, H3000YS). A total of 93 units have been identified for recall, with distribution worldwide.

These systems may have been transported or relocated without proper support for their detector mechanisms. When support is inadequate during transport or repositioning, excessive mechanical load can be applied to the detector mounting system. This can potentially cause the detector to fall.

A detector fall could result in life-threatening bodily injury. Facilities with affected systems should verify their equipment is properly supported and contact GE Healthcare with any questions about whether their system is included in the recall.

The recalled product

Product
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine System
Hazard
  • detector-fall
  • impact-injury
  • 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) H3000WN: UDI/DI N/A
  • System ID YN1593
  • Serial Number 16433. 2) H3000YM: UDI/DI N/A
  • System ID 602406INF
  • Serial Number 16012
  • UDI/DI N/A
  • System ID 928537INF
  • Serial Number 16021
  • System ID 661633NM1
  • Serial Number 15013
  • Serial Number 16051
  • System ID 619482INFINIA
  • Serial Number 16007
  • System ID 626359INF2
  • Serial Number 16175
  • System ID 626359INF1
  • Serial Number 16177
  • System ID 916983INFN1
  • Serial Number 16059
  • System ID 858554INF1

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category