Events

Retiro De Equipo (Recall) de Device Recall NonCertified laser diode component

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 Ii - Vi Incorporated.

¿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
    80020
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1614-2018
  • Fecha de inicio del evento
    2017-12-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164228
  • 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
    unknown device name - Product Code N/A
  • Causa
    Affected diodes incorporated in the laser sights emitted greater than the 5 mw limit.
  • Acción
    Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.

Device

Device Recall NonCertified laser diode component
  • Modelo / Serial
    Model Numbers: 25-0655 & 25-0657
  • Distribución
    US Distribution to Oregon.
  • Descripción del producto
    11-VI Incorporated Laser diode component || Non-certified laser diode component used in laser sights for firearms
  • Manufacturer
    Ii - Vi Incorporated

Manufacturer

Ii - Vi Incorporated
  • Dirección del fabricante
    Ii - Vi Incorporated, 375 Saxonburg Blvd, Saxonburg PA 16056-9430
  • Empresa matriz del fabricante (2017)
    II-VI, Inc.
  • Source
    USFDA