Events

Recall of Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)

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-2016-RN-01216-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01216-1
  • 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
    The manufacturer has become aware that due to a software issue, if the compressed air supply of the machine is lost right before or during product supply (dlc detergent, aperlan poka-yoke agent a/b disinfectant), and after cycle start, and not re-established before cycle end, the machine does not launch or complete the product supply when reprocessing a scope. as a result, no alarm is triggered.
  • Action
    Getinge is advising users of interim instructions to follow. Users are advised to carefully examine the printer ticket at the end of each reprocessing cycle to ensure there are 3 lines printed for DLC weight, Disinfectant A and B weights are OK. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 20/02/2017.

Device

Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)
  • Model / Serial
    Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)Model Number: 01280010Serial Numbers: 4H120383, 4H120384ARTG Number: 228574
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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