The Recall Desk
HighFDA (Devices)·Z-1198-2014·Announced 2014-03-19

GE Healthcare Recalls Infinia Nuclear Medicine Systems for Detector Motion Risk

GE Healthcare is recalling Infinia and Infinia Hawkeye Nuclear Medicine Systems due to a potential safety issue where the detector may drift toward the patient.

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: The recall is classified as FDA Class II. The hazard involves a mechanical defect (detector drifting toward the patient) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).

Plain-English summary

GE Healthcare, LLC is recalling GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems, including the Hawkeye Option for Dual-Head Variable Angle Gamma Camera and GE Quasar Nuclear Medicine Systems. The recall involves 3,062 units distributed worldwide, including 1,182 units in the United States and 1,880 units outside the US.

The recall is issued due to a potential safety issue related to unintended radial detector motion. This failure mode may occur during patient setup or at the end of a patient scan. The issue has been observed on a single system where the detector moved to the home position and then slowly started drifting inward toward the patient. This movement generated both visual and audio alert conditions on both the console and the gantry.

Affected devices are used for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The systems are used in Oncology, Cardiology, Neurology, and other clinical diagnostic imaging applications. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

Product
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: T
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Imaging
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)

  • Serial Numbers for all devices: 22
  • 343
  • 1002
  • 1003
  • 1006
  • 1007
  • 1008
  • 1010
  • 1012
  • 1013
  • 1016
  • 1018
  • 1019
  • 1021
  • 1025
  • 1026
  • 1027
  • 1034
  • 1035
  • 1038

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · mechanical failure

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