Events

Recall of EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)

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-00319-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00319-1
  • 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
    Johnson & johnson medical is issuing a product correction for the evotech endoscope cleaner and reprocessor system after receiving reports of smoke emanating from the system and upon further investigation has discovered that a circuit board malfunction may occur in the channel control manifold sub-assembly. this failure can potentially cause the following outcomes for the cycles: 1. full reprocessing cycle (cleaning and hld) - if this issue were to occur while running a full automated cleaning and high level disinfection (hld) cycle, there is potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes, 2. hld-only cycle - if this issue were to occur during reprocessing of endoscopes qualified for the hld only cycle, there is potential for an inadequate amount of high-level disinfectant solution to be sent through some endoscope channels.
  • Action
    Johnson & Johnson Medical Pty Ltd is providing the users with the instructions to prevent the issues from occurring.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • Model / Serial
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product number: 50004ARTG: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd