Events

Recall of Leica M525 F40 Surgical Microscopes

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-2017-RN-00771-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00771-1
  • 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 the instructions for use (ifu) and warnings are not always followed by users of the leica m525 f40 surgical microscopes, in particular for transportation and positioning in the operating room (or). due to this, additional waning stickers have been introduced for the leica m525 f40, in addition to a quick reference guide for transporting and position in the or which can be attached to the instrument.Using the m525 f40 improperly during transport and positioning can have an adverse effect on the stability of the device. in extreme cases, improper use during transport and positioning can cause tilting of the device. leica microsystems has received two reports where a m525 f40 started tilting due to improper handling.
  • Action
    1. Leica Microsystems is sending warning stickers and “quick reference guides for transport and positioning in the OR”. 2. Users are to arrange the fixation of the warning stickers on the instruments, inform or personnel accordingly and fill out the supplied acknowledge form.

Device

Leica M525 F40 Surgical Microscopes
  • Model / Serial
    Leica M525 F40 Surgical MicroscopesMaterial Number: 10448096Serial Numbers: 010708001, 010906002, 060505002, 080508001, 100105001, 100608002, 110608001, 180205002, 180410001, 230507001, 231209001, 240609001, 260609001, 290508001, 301106002ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd