Events

Recall of SURGICAL MICROSCOPE FOOTSWITCH

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
    17409
  • Event Risk Class
    II
  • Event Initiated Date
    2010-03-29
  • 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
    Received twelve (12) complaints stating that the pedals of the footswitch/wireless type b are sticking and the zoom/focus is moving to the end position striking the patient's eye and potentially causing injury when a non-contact viewing system is attached.

Device

SURGICAL MICROSCOPE FOOTSWITCH
  • Model / Serial
    Model Catalog: 10448406 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10445600 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10448164 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10445599 (Lot serial: MORE THAN 10 SERIAL NUMBERS.); Model Catalog: 10448407 (Lot serial: MORE THAN 10 SERIAL NUMBERS.)
  • Product Description
    SURGICAL MICROSCOPE FOOTSWITCH
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.