Events

Retiro De Equipo (Recall) de Device Recall Surgical microscope

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Leica Microsystems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1269-2012
  • Fecha de inicio del evento
    2012-02-27
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107745
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Microscope, surgical, general & plastic surgery - Product Code FSO
  • Causa
    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.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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,
  • Descripción del producto
    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.
  • Dirección del fabricante
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA