Events

Recall of GE X-Ray Systems with CRT Video Monitor Suspensions

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
    15819
  • Event Initiated Date
    2013-12-09
  • 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
    It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that your system has not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension; however, missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue.
  • Action
    Product to be modified

Device

GE X-Ray Systems with CRT Video Monitor Suspensions
  • Model / Serial
    Model: Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII, Affected: All CRT Monitor suspension installed since Jan 1993 with products Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC