The Recall Desk
HighFDA (Devices)·Z-0889-2025·Announced 2025-01-22

GE Healthcare Nuclear Medicine Systems Detector Fall Risk from Improper Transport

GE Healthcare recalled 116 nuclear medicine imaging systems worldwide due to risk that systems transported without proper detector support could experience 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 FDA Class II device recall presents serious hazard (detector fall and life-threatening injury potential) but no reported illnesses or injuries. As a preventive recall of a risk-of-harm product where injury has not yet been reported, it meets the criteria for High severity.

Plain-English summary

GE Healthcare recalled 116 nuclear medicine imaging systems worldwide, including Brivo NM 615 and related models. The recall was issued after GE discovered that certain units may have been transported or relocated without proper detector support.

When these systems lack proper detector support during transport or relocation, excessive load can be applied to the detector mounting mechanisms. This can potentially result in detector falls, which pose a risk of life-threatening bodily injury to patients and medical personnel.

Affected models include Infinia, VariCam/VG/VH, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640, in addition to the Brivo NM 615.

The recalled product

Product
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine Imaging System
Hazard
  • detector-fall
  • fall-hazard

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) 5376204-15: UDI/DI 00840682145503
  • System ID 502629NMGD
  • Serial Number NT2UG2100002BH
  • UDI/DI 00840682117869
  • System ID 509455BRIVO
  • Serial Number NT24G1700010BH
  • UDI/DI N/A
  • System ID 248544D630
  • System ID 501552D615
  • Serial Number NT24G1600023
  • UDI/DI Not Available
  • System ID 100035454149
  • Serial Number T2CG15015/100035454149
  • System ID 337643NM
  • Serial Number NT24G1600021
  • System ID 718963B615
  • Serial Number NT24G1700009
  • System ID Not Available
  • Serial Number NT24G1600020
  • Serial Number NT24G1700010

Distribution

Distribution scope not specified by the agency.

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