Events

Recall of Device Recall Leica M525 OH4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Microsystems (Schweiz) Ag.

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
    64601
  • Event Risk Class
    Class 2
  • Event Number
    Z-2176-2013
  • Event Initiated Date
    2012-12-18
  • Event Date Posted
    2013-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116798
  • 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
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • Reason
    The brake in the z axis and/or brakes in the ab and c axes failed during installation.
  • Action
    The firm, Leica Microsystems, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to DISCONTINUE USE until your system software is updated and to complete and return the attached Acknowledgement Form via email at LMGRA@leica-microsystems.com or fax to: 847-236-3747 or +41 71 726 32 49 within 10 working days after receipt of field safety notice. Your Leica Mycrosystems will contact you to make the necessary arrangements to complete an upgrade at no charge to the customers. If you have any further questions, contact Regulatory Affairs/Quality Assurance Manager at 847-405-5413 or +41 71 726 32 16.

Device

Device Recall Leica M525 OH4
  • Model / Serial
    Serial Numbers: OH4-84712,  OH4-84812,  OH4-84912
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) including states of: AK, CA, CO, NY, and OR; and countries of: Belarus, China, Hong Kong, India, Indonesia, Italy, Norway, South Africa, Spain, Sweden, Turkey, and Vietnam.
  • Product Description
    Surgical microscope || The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
  • Manufacturer
    Leica Microsystems (Schweiz) Ag

Manufacturer

Leica Microsystems (Schweiz) Ag
  • Manufacturer Address
    Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny-Strasse, Heerbrugg Switzerland
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA