Events

Recall of LEICA M720 OH5 SURGICAL MICROSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS INC..

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
    53327
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Leica microsystems schweiz informed the importer that an electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could lead to an unforeseen behavior. 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. the observed malfunction can only occur on devices that include a 400w power supply type hbx400.

Device

LEICA M720 OH5 SURGICAL MICROSCOPE
  • Model / Serial
    Model Catalog: M720 OH5 (Lot serial: OH5-20238); Model Catalog: M720 OH5 (Lot serial: OH5-67914); Model Catalog: M525 OH4 (Lot serial: OH4-112214); Model Catalog: M720 OH5 (Lot serial: OH5-51313); Model Catalog: M525 OH4 (Lot serial: OH4-101213); Model Catalog: M720 OH5 (Lot serial: OH5-49112)
  • Product Description
    LEICA M720 OH5 SURGICAL MICROSCOPE WITH 400W ILLUMINATION
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.