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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00350-1
Product Name/Description CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2

ARTG Number: 295240
Carl Zeiss - Camera, fundus
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 27/04/2018
Responsible Entity Carl Zeiss Pty Ltd
Reason/Issue It has been identified that it is possible for the CLARUS 500 to allocate patient data to the wrong patient. This may occur when the operator exits the Acquire page to the Patient Management page while the system is in process of creating the montage of two or more images. The constituent images from which the montage is derived are still assigned to the correct patient. They can be viewed individually or manually montaged to recreate the missing information. The error is detectable as there will be no constituent image to support the montage for the affected patient.
Recall Action Product Defect Correction
Recall Action Instructions Zeiss will be conducting a software update by the ZEISS Service Centre and important changes to the User Manual for CLARUS 500 which has already been supplied to users. A software update is available for the CLARUS 500 and updated user manual is available accordingly. The update only applies to CLARUS 500 devices with software versions 1.0.0, 1.0.1, and 1.0.2.

This action has been closed out on 04/02/2019
Contact Information 1300 365 470 - Zeiss Service Centre