Events

Recall of 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
    21428
  • Event Initiated Date
    2017-05-18
  • 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
    An incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems. this incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2), which could lead to hypercarbia.
  • Action
    Instructions for use to be updated

Device

Anaesthesia Work Stations
  • Model / Serial
    Model: , Affected: Carestation 620, 650 and 650c
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc