Events

Recall of GE Avance, Amingo, Avamce and Aisys Anaesthesia Work Stations

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Datex-Ohmeda Inc.

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
    15482
  • Event Initiated Date
    2013-10-07
  • 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
    While operating in presure control ventilation - volume guarantee (pcv-vg) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit).Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume.
  • Action
    Software to be upgraded

Device

GE Avance, Amingo, Avamce and Aisys Anaesthesia Work Stations
  • Model / Serial
    Model: , Affected: , Software version: 8.00 and 10.00
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc