Events

Recall of Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)

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-2015-RN-00098-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00098-1
  • 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
    It has been identified that specific combinations of engstrom ventilator casters and bases pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing). a fall/tip of the engstrom ventilator can result in serious injury to patients or clinical staff.
  • Action
    GE is replacing all affected accessory carts. End users are advised that they can continue to use the cart until replaced, however the casters must be checked for signs of damage and loosening. This action has been closed-out on 03/08/2016.

Device

Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as p...
  • Model / Serial
    Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)Serial Numbers: CBCN01062 through CBCQ01396ARTG Number: 108308
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd