Events

Recall of Device Recall Leica M525 F50 surgical microscope

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
    62114
  • Event Risk Class
    Class 2
  • Event Number
    Z-2053-2012
  • Event Initiated Date
    2012-06-04
  • Event Date Posted
    2012-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109868
  • 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
    Leica microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when leica m525 f50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
  • Action
    Leica Microsystems sent an Urgent Medical Device letter dated June 4, 2012 to the affected customers. The letter described the product, problem and actions to be taken. The customers were informed that the Leica surgical microscope M525 F50 required a software upgrade. Customers were instructed to NOT USE a remote video adapter or motorized video adapter until the required software upgrade has been installed by their Leica Microsystems representative. The customers were requested to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the serial numbers of the units at their facilities and to fax it back to Leica Microsystems at (847) 236-3747.

Device

Device Recall Leica M525 F50 surgical microscope
  • Model / Serial
    Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311002, 90611001, 260711001, 20911001, 200911001, 210911001, 111011001, 141011001, 241011001, 121211001, 141211001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 90811001, 200312001, 50412001, 110112002, 280611001, 241011002, 20312001, 101011001 and 270911001
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the states of: California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, including Puerto Rico, and the countriy of Canada.
  • Product Description
    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland || Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Manufacturer Address
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA