The Recall Desk
HighFDA (Devices)·Z-0896-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Recalled Due to Detector Fall Risk

GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls 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 medical device recall with potential for life-threatening injury but no reported illnesses or injuries. The hazard is theoretical rather than documented, placing it at Score 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare has recalled certain nuclear medicine imaging systems including the Optima NM/CT 640, Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, and Discovery NM/CT 670. The recall affects approximately 430 units distributed worldwide.

GE Healthcare became aware that these systems could have been transported or relocated without proper detector support. When not properly supported during transport or relocation, excessive load can be applied to the detector mounting mechanisms.

This excessive load on the mounting mechanisms can potentially result in a detector fall, which can lead to life-threatening bodily injury.

The recalled product

Product
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine Imaging
Hazard
  • detector-fall
  • mechanical-failure
  • bodily-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) H3100JZ: UDI/DI N/A
  • System ID UAB640
  • Serial Number 26139/25146
  • UDI/DI N/A
  • System ID 479441N640
  • Serial Number 26150/25152
  • System ID 480BAY640
  • Serial Number 26195/25195
  • System ID 602UACC640
  • Serial Number 26191/25189
  • System ID 520VA640
  • Serial Number 26329/640V25328
  • System ID 530756OPT1
  • Serial Number ONMW26439/640W25433
  • System ID 626359D640
  • Serial Number 26109/25111
  • System ID 858824NM640
  • Serial Number 26221/25222
  • System ID 909558NM640
  • Serial Number 26297/640V25296

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category