Events

Retiro De Equipo (Recall) de OPTILITE HOLMIUM FIBER ASSEMBLY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES.

¿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
    71305
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-23
  • 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
    The reprocessing instructions may not provide sufficiently detailed information for the cleaning disinfection and sterilization of these products. our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards.

Device

OPTILITE HOLMIUM FIBER ASSEMBLY
  • Modelo / Serial
    Model Catalog: HLF-M940-CNV-CAN (Lot serial: all lots); Model Catalog: HLF-M550-CNV-CAN (Lot serial: all lots); Model Catalog: HLF-M365-SMA-CAN (Lot serial: all lots); Model Catalog: HLF-M365-CNV-CAN (Lot serial: all lots); Model Catalog: SMH1020F (Lot serial: all lots); Model Catalog: HLF-M273-CNV-CAN (Lot serial: all lots); Model Catalog: SMH1010F (Lot serial: all lots); Model Catalog: SMH1060F (Lot serial: all lots); Model Catalog: SMH1040F (Lot serial: all lots); Model Catalog: HLF-M273-SMA-CAN (Lot serial: all lots); Model Catalog: HLF-M940-SMA (Lot serial: all lots); Model Catalog: HLF-M940-CNV (Lot serial: all lots); Model Catalog: HLF-M550-SMA (Lot serial: all lots); Model Catalog: HLF-M273-CNV (Lot serial: all lots); Model Catalog: HLF-M365-SMA (Lot serial: all lots); Model Catalog: HLF-M365-CNV (Lot serial: all lots); Model Catalog: HLF-M273-SMA (Lot serial: all lots); Model Catalog: HLF-M550-CNV (Lot serial: all lots)
  • Descripción del producto
    Optilite Holmium Laser Fibers;OPTILITE HOLMIUM FIBER ASSEMBLY;OPTILITE MULTI USE HOLMIUM LASER FIBERS
  • Manufacturer
    XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES

Manufacturer

XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES
  • Dirección del fabricante
    ALAMEDA
  • Empresa matriz del fabricante (2017)
    Xintec Corporation
  • Source
    HC