Recall of LEICA M525 F50 SURGICAL MICROSCOPES

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

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
    55895
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-04
  • Event Country
  • 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 evaluated data showing that a malfunction resulting in an illumination reduction can be observed when leica m525 f50 srugical microscope is used in combination with a remote control connected to a remote video adapter (rva) or a motorized dual video adapter (dva).

Device

  • Model / Serial
    Model Catalog: M525 F50 (Lot serial: 20412001); Model Catalog: M525 F50 (Lot serial: 80411001); Model Catalog: M525 F50 (Lot serial: 110311001); Model Catalog: M525 F50 (Lot serial: 300911001); Model Catalog: M525 F50 (Lot serial: 40811001); Model Catalog: M525 F50 (Lot serial: 90312001); Model Catalog: M525 F50 (Lot serial: 120312001); Model Catalog: M525 F50 (Lot serial: 260112001)
  • Product Description
    Leica M525 F50 Surgical Microscopes
  • Manufacturer

Manufacturer