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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00051-1
Product Name/Description FORUM Software

ARTG Number: 163245
Recall Action Level Retail
Recall Action Classification Class I
Recall Action Commencement Date 22/01/2015
Responsible Entity Carl Zeiss Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 02 9020 1339 - Carl Zeiss