Events

Recall of GE Drive Gas Check Valve on 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
    19664
  • Event Initiated Date
    2016-01-18
  • 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 drive gas check could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. if this issue is left unresolved it could result n excessive or prolonged pressure in the patient breathing circuit during ventilatoin potentially resulting in barotrauma.There have been no injuries reported as a result of this issue.
  • Action
    Product to be modified

Device

GE Drive Gas Check Valve on Anaesthesia Work Stations
  • Model / Serial
    Model: Aespire 7900, Aespire View 7900, Aestiva MRI, Aisys, Aisys CS2, Avance and Avance CS2 installed from April 20 2015 through to Oct 2015., Affected:
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc