Events

Recall of Slit Lamp

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-01150-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01150-1
  • 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 post market surveillance activities, carl zeiss has determined that in certain devices there is an increased probability of failure of the power supply on/off switch, and surface corrosion of the mirror which changes the direction of the light projection. there is no potential health hazard and the probability of injury is extremely unlikely. in a worst case scenario, a burning smell may result from a thermal event at the power supply on/off switch. issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. the slit projection may be slightly darker and more diffused.
  • Action
    Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.

Device

Slit Lamp
  • Model / Serial
    Slit LampModel Number: SL 220 Serial Numbers: 970712XXXX and 970714XXXXARTG Number: 94353
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd