Events

Recall of EVOTECH Endoscope Cleaner and Reprocessor (ECR)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-2013-RN-01344-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01344-1
  • 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 pentax eg-3670urk flexible endoscope has been qualified for use with the evotech ecr, however it cannot currently be processed in the evotech ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
  • Action
    Johnson & Johnson Medical is advising users with the Pentax EG-3670URK scope to manually clean and undertake a high level of disinfection prior to use. The EVOTECH ECR can continue to be used in accordance with the user guide for all other endoscopes that have been qualified and validated. A software update will be implemented as a permanent fix.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)

Manufacturer

Johnson & Johnson Medical Pty Ltd