Events

Recall of Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Leica Microsystems 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-2016-RN-00158-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00158-1
  • 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 come to the manufacturer's attention that an electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could lead to an unforeseen behaviour:an electronic component in one of the two illumination units can potentially overheat, resulting in modest smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
  • Action
    Leica is advising users that the microscope will continue to function if the failure occurs, and is providing users with instructions on how to switch the microscope to the back-up illumination unit. Leica will be providing a replacement power supply cable to prevent the issue from occurring. This action has been closed-out on 25/01/2017.

Device

Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W Illumination
  • Model / Serial
    Leica M525 OH4 and M720 OH5 Surgical Microscope Stands with 400W IlluminationMaterial Numbers: 10448480 and 10448662Serial Numbers: OH5-31311, OH5-51813, OH5-53113, OH5-55313, OH5-53413, OH5-57013, OH5-56613, OH4-107114 and OH5-67314ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd