Events

Recall of Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)

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-2013-RN-01256-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01256-1
  • 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
    Leica microsystems has identified that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button. run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45 degrees, 135 degrees, 225 degrees or 315 degrees. in addition, the run-on will stop if any other activation of the xy occurs. the xy run-on is disruptive as the adjustment to the field of view could take up to 24 seconds longer than usual, however there is a low risk to patients.
  • Action
    Leica is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent fix.

Device

Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)
  • Model / Serial
    Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)Material Number: 10448505Serial numbers: 260213001, 70613002, 80911001, 110613001, 180712001, 30913001Manufactured from 10 May 2010 to 18 November 2013ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd