Events

Recall of GE Signa Magnetic Resonance Imaging System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Medical Systems LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    14656
  • Event Initiated Date
    2013-05-16
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    For clariview and screen save from gvtk (gems visualization toolkit) viewer, the mr product can generate image headers with non-unique series identifiers, which when exported to some pacs systems, results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases, patient identifying annotation remains correct.
  • Action
    Software to be upgraded

Device

GE Signa Magnetic Resonance Imaging System
  • Model / Serial
    Model: Models: 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, Affected: PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350)
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC