Events

Recall of FORUM Software

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carl Zeiss 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-2015-RN-00051-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00051-1
  • 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
    Forum is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. it is intended to work with other forum applications.Forum correctly displays the optical coherence tomogram (oct) retinal b-scan when initially rendered, but a different b-scan tomogram is potentially displayed on subsequent renderings within a user session.Therefore, in certain circumstances an incorrect oct retinal b-scan tomogram scan may be displayed when retrospectively reviewing the available scans.This gives rise to a risk of a healthcare professional making a medical decision for the patient after viewing the wrong scan to what they requested.No incidents have been reported in australia or new zealand.
  • Action
    An initial workaround is provided to users in the Customer Letter whilst a permanent Software fix is being developed for rollout in February 2015. This action has been closed-out on 18/07/2016.

Device

FORUM Software

Manufacturer

Carl Zeiss Pty Ltd