Events

Recall of i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by IQ Medical.

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-2014-RN-01265-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01265-1
  • 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
    After upgrading the cassini software to version 2.0.0, the cassini patient database may have beencompromised, resulting in patient examination data being linked to the wrong patient.
  • Action
    Technical support representative will contact affected customers to inspect and, if necessary, to correct the issue. During the restoration process, the Cassini device will be locked and cannot be used. This is estimated to take 1 to 3 hours. Until the database integrity has been ensured, users are advised not to use patient examination data unless verified to be correctly associated with the patient. A software patch is under development (version 2.0.1, expected mid-December) including making a back-up before updating and a database check before and after an update. This action was undertaken prior to consultation with the Therapeutic Goods Administration. This action has been closed out on 29/01/2016.

Device

i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0
  • Model / Serial
    i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0ARTG Number: 219343 (TBC)
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical