The Recall Desk

FDA (Devices) recall action 67464

GE Healthcare, LLC recalled 3 products on 2014-03-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-03-19
Critical
0
Units
—

Why these products were recalled

Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-03-19

    GE Healthcare Recalls Elscint APEX Helix Gamma Cameras for Motion Risk

    GE Healthcare is recalling 3,062 Elscint APEX Helix gamma cameras due to a potential safety issue where the detector may drift toward the patient.

    Product
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scannin
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-03-19

    GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices

    GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various a
    Category
    Distribution
    2 states