Events

Recall of Kenex Suspension Arm with Radiation Shield and/or Surgical Lamp

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Kenex Electro Medical 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
    16496
  • Event Initiated Date
    2014-04-08
  • 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
    Ge healthcare has recently become aware of an improper installation of the kenex suspension arm of a radiation shield. the suspension arm was not installed per specified installation requirements. there has been one reported incident of a radiation shield falling from the ceiling causing a minor injury.
  • Action
    Product to be modified

Device

Kenex Suspension Arm with Radiation Shield and/or Surgical Lamp

Manufacturer

Kenex Electro Medical Ltd