Events

Recall of Device Recall 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
    61294
  • Event Risk Class
    Class 2
  • Event Number
    Z-1269-2012
  • Event Initiated Date
    2012-02-27
  • Event Date Posted
    2012-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107745
  • 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 screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.
  • Action
    The firm, Leica Microsystems, sent a "Medical Device Correction" letter dated February 27, 2012 to the affected customers via e-mail on the same date. The letter described the product, problem and action to be taken. The customers were informed that the Leica M820 and M844 C19 surgical microscopes require upgrading. An upgrade kit will be provide for replacement of the flange and axis of the touch panel/control unit carrier. The Customers were instructed to NOT USE the affected Leica surgical microscope until the unit has been upgraded by their Leica Microsystems representative and to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the serial numbers of the unit at their facility and fax it back to Leica at 1-847-236-3747. If they have any questions, contact Director, Global Product Quality Management at 1-847-317-7209.

Device

Device Recall Surgical microscope
  • Model / Serial
    article 10448196: serial numbers 17091004, 20911002, 26110801, 31207001, 31207002, 61006001, 61006002, 91208002, 101208001, 101210002, 140508002, 151209002, 160806002, 260811001, 261108001 and 261108002;  article 10448197: serial numbers 11010001, 50510002, 81007003, 110507002, 130707001, 130707003, 160910008, 180607001, 230909001, 270407006 and 300307001
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: California, Connecticut, Kansas, Missouri, New York, North Dakota, Ohio, Pennsylvania, Texas and Utah; and countries of: Japan and South Africa,
  • Product Description
    Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microscope, article 10448197; ceiling mounted surgical microscopes; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland;; The intended use of the microscope is for improving the 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