Events

Recall of GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-2018-RN-00906-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00906-1
  • 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
    Getinge have identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the eds8. this potential for malfunction is caused by a device design issue. it is identified that the delivered pressure and flow rate of the eds8 compressor is too low. under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5l/min airflow required to properly dry/store the endoscopes.Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
  • Action
    Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.

Device

GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor
  • Model / Serial
    GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor Model Numbers: 01039717 – Right hinge EDS8-R and 01039716 – Left hinge EDS8-L ARTG Number: 276061(Getinge Australia Pty Ltd - Endoscope drying/storage chamber)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA