Events

Recall of Device Recall Leica Footswitch, Type B

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    55241
  • Event Risk Class
    Class 2
  • Event Number
    Z-1632-2010
  • Event Initiated Date
    2010-03-29
  • Event Date Posted
    2010-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90391
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    surgical microscope footswitch - Product Code FSO
  • Reason
    The pedals of the footswitch type b stick and the zoom/focus moves to the end position.
  • Action
    Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.

Device

Device Recall Leica Footswitch, Type B
  • Model / Serial
    stock number 10445599, serial numbers 90909001 and 301109002;  stock number 10445600, serial numbers 91009001, 81209001, 80909001, 8011001, 71009002, 71009001, 70110002, 61009002, 41209004, 41209002, 291009004, 271009004, 261109001, 250909001, 230909001, 211209005, 211209004, 211009004, 180909002, 180909001, 180110002, 171209002, 161209002, 160909001, 151209001, 140110001, 121009001, 120110002, 120110001, 111209002, 111209001, 110909003, 110909002, 110909001, 11009003, 101209003, 101209002, 101109002 and 100909001; stock number 10448164, serial numbers 80909001, 71209001, 70909002, 31209004, 31209003, 31209002, 31209001, 301009001, 300909001, 291009001, 290909002, 290909001, 240909002, 240909001, 230909001, 180909005, 180909004, 160909002, 100909002 and 100909001;
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
  • Product Description
    Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : || a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; || b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; || c) MFS18, stock number 10448164, a 16 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Manufacturer Address
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA