Events

Rappel de OPTILITE HOLMIUM FIBER ASSEMBLY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par XINTEC CORPORATION D/B/A CONVERGENT LASER TECHNOLOGIES.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71305
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-06-23
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Description du dispositif
    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