Events

Recall of Fujifilm ED-530XT Duodenoscope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm 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-00034-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00034-2
  • 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 operation manuals have been revised to reflect newly validated manual cleaning and high-level disinfection procedures. this action is being taken as a result of reports of multi-drug resistant bacteria on endoscopesused for endoscopic retrograde cholangiopancreatogram (ercp) procedures. revisions have been made to the ed-530xt operation manuals, “preparation and operation” and “cleaning, disinfection and storage.” these revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush to be used for the cleaning of the duodenoscope’s distal tip, forceps elevator and elevator recess, in addition to use of the existing fujifilm valve cylinder cleaning brush.
  • Action
    FujiFilm is providing users with updated instructions manuals and samples of the new disposable distal end cleaning brush. All previous versions of the IFU should be discarded. This action has been closed-out on 01/03/2018.

Device

Fujifilm ED-530XT Duodenoscope
  • Model / Serial
    Fujifilm ED-530XT Duodenoscope Serial Numbers: MD102A129, MD102A130ARTG Number: 139172
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd