Events

Retiro De Equipo (Recall) de Device Recall Leica Footswitch, Type B

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
    55241
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1632-2010
  • Fecha de inicio del evento
    2010-03-29
  • Fecha de publicación del evento
    2010-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90391
  • 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
    surgical microscope footswitch - Product Code FSO
  • Causa
    The pedals of the footswitch type b stick and the zoom/focus moves to the end position.
  • Acción
    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
  • Modelo / 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;
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
  • Descripción del producto
    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.
  • Dirección del fabricante
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA