Events

Recall of All Carestation 620, 650 and 650c Anaesthesia systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2017-RN-01300-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01300-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ge healthcare has recently become aware that an incomplete seal can exist between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems. an incomplete seal can allow rebreathing of patient gases that have bypassed the co2 absorbent material and could result in unintended elevated levels of inspired co2 (fico2), which could lead to hypercarbia. to date, there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users as an interim solution to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathes if elevated FiCO2 levels are observed. If the FiCO2 levels cannot be adequately reduced with this action, users should consider switching to another anaesthesia delivery device. GE is releasing revised parts that minimise the likelihood of incomplete gas flow through the CO2 absorbent canister. GE will be in contact with affected customers to arrange for correction. Going forward, the updated parts will be included in the 12-month preventative maintenance replacement schedule for the Carestation 600 Series system.

Device

All Carestation 620, 650 and 650c Anaesthesia systems

Manufacturer

GE Healthcare Australia Pty Ltd