Events

Recall of GE Proteus XR/a X-ray systems

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

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
    17752
  • Event Initiated Date
    2014-11-25
  • 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
    The proteus xr/a and revolution xr/d x-ray service manuals have been updated to further ensure proper re-installation. reinstallation errors may result in a fall of a collimator while the system is in use, resulting in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
  • Action
    Instructions for use to be updated

Device

GE Proteus XR/a X-ray systems

Manufacturer

GE Hualun Medical Systems Co Ltd