Events

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
    27214
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-04
  • 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) ag evaluated data of an internal report showing that it is possible an unspecified behaviour of the optional xy-unit for the leica m525 f50 and leica m525 c50. to date have not received any customer complaints involving a malfunction in the xy unit. by moving the xy-joysticks of the handle or the footswitch diagonally it is possible that the xy-unit will unintentionally proceed in one direction until the end stop is reached. consecutive entries in diagonal direction will contribute to the probability to stipulate this problem. after the xy movement is stopped by end stop or interruption through orthogonal xy-joystick command the xy-unit can be operated normally.

Device

LEICA M525 F50 SURGICAL MICROSCOPES
  • Model / Serial
    Model Catalog: M525 F50 (Lot serial: 271212001); Model Catalog: M525 F50 (Lot serial: 60312001); Model Catalog: M525 F50 (Lot serial: 110513001); Model Catalog: M525 F50 (Lot serial: 30613001)
  • Product Description
    LEICA M525 F50 SURGICAL MICROSCOPES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA