Events

Recall of GE DashPort 2 Patient Monitor

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
    13319
  • Event Initiated Date
    2012-08-14
  • 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 manufacturer had advised that there are several potential issues with the dash 3000/4000/5000 patient monitors;, 1/ dash stops communication on the unity network resulting in loss of monitoring at the centra station, 2/ dash displays distorted ecg waveform in combination monitoring mode, 3/ dash incorrectly becomes time master on the unity network, 4/ dash date reverts to 1993, 5/ dashport 2 stops communicating on the unity network resulting in loss of monitoring at the central station.
  • Action
    Software to be upgraded

Device

GE DashPort 2 Patient Monitor

Manufacturer

GE Medical Systems Information Technologies