Events

Recall of GE Treadmill

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 Information Technologies.

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
    22860
  • Event Initiated Date
    2018-04-26
  • 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
    A performance issue with customer owned spare parts, t2100 microflex drive (2026182-002 or 2026182-004), was not addressed with a previous safety correction in 2015., if a spare part drive does not have the fmi correction label attached and is ge part number (2026182-002 or 2026182-004), or abb part number (fmh2a09tr-en43eq, fmh2a09tr-en43e, fmh2a09tr-en43e/12 or fmh2a09tr-en43gz), the firmware on the drive was not updated and spare part drive has not been corrected.
  • Action
    Manufacturer to issue advice regarding use

Device

GE Treadmill

Manufacturer

GE Medical Systems Information Technologies