Events

Retiro De Equipo (Recall) de LEICA M525 F50 SURGICAL MICROSCOPES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA MICROSYSTEMS CANADA.

¿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
    27214
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-12-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Leica microsystems (schweiz) ag evaluated data of an internal report showing that it is possible an unspecified behaviour of the optional xy-unit for the leica m525 f50 and leica m525 c50. to date have not received any customer complaints involving a malfunction in the xy unit. by moving the xy-joysticks of the handle or the footswitch diagonally it is possible that the xy-unit will unintentionally proceed in one direction until the end stop is reached. consecutive entries in diagonal direction will contribute to the probability to stipulate this problem. after the xy movement is stopped by end stop or interruption through orthogonal xy-joystick command the xy-unit can be operated normally.

Device

LEICA M525 F50 SURGICAL MICROSCOPES
  • Modelo / Serial
    Model Catalog: M525 F50 (Lot serial: 271212001); Model Catalog: M525 F50 (Lot serial: 60312001); Model Catalog: M525 F50 (Lot serial: 110513001); Model Catalog: M525 F50 (Lot serial: 30613001)
  • Descripción del producto
    LEICA M525 F50 SURGICAL MICROSCOPES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA