Events

Recall of VisuMax Laser

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-2017-RN-00318-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00318-1
  • 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
    Based on complaints, carl zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (ups)-module. it was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the ups at the rear side of the machine. there were no patient involvement and no adverse consequences associated with these complaints.
  • Action
    The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.

Device

VisuMax Laser
  • Model / Serial
    VisuMax LaserSerial numbers starting with 963599 up to 1157772ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd