Events

Recall of CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2

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-2018-RN-00350-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00350-1
  • 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
    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.
  • Action
    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.

Device

CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2
  • Model / Serial
    CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2ARTG Number: 295240Carl Zeiss - Camera, fundus
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd