Events

Rappel de ILED 5 SURGICAL LIGHT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par OLYMPUS CANADA INC..

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
    26973
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-01-25
  • 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
    Manufacturer has received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determined the root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly the spring arm of the lighting system can descend over time and eventually fall from the central axis. when the snap ring has been installed properly the potential for the lighting system to fall does not exist.

Device

ILED 5 SURGICAL LIGHT
  • Modèle / numéro de série
    Model Catalog: 1510-2 (Lot serial: All lots); Model Catalog: T300 (Lot serial: All Lots); Model Catalog: 337556 (Lot serial: All lots); Model Catalog: 1500 (Lot serial: All lots); Model Catalog: 1510 (Lot serial: All lots); Model Catalog: 337547 (Lot serial: All lots); Model Catalog: 337541 (Lot serial: All lots); Model Catalog: TE300H (Lot serial: All Lots); Model Catalog: TE551-2 (Lot serial: All Lots); Model Catalog: TE330 (Lot serial: All Lots); Model Catalog: 337542 (Lot serial: All lots); Model Catalog: 337618 (Lot serial: All lots); Model Catalog: 1331 (Lot serial: All lots); Model Catalog: 1430 (Lot serial: All lots); Model Catalog: 337540 (Lot serial: All lots); Model Catalog: 337550 (Lot serial: All lots); Model Catalog: 1340 (Lot serial: All lots); Model Catalog: 1310 (Lot serial: All lots); Model Catalog: 1300 (Lot serial: All lots); Model Catalog: 1330 (Lot serial: All lots); Model Catalog: 1320 (Lot serial: All lots); Model Catalog: T510-2 (Lot serial: All Lots); Model Catalog: T510 (Lot serial
  • Description du dispositif
    ILED 5 SURGICAL LIGHT;TRULIGHT 5000 SURGICAL LIGHT;TRULIGHT 3000 SURGICAL LIGHT;ILED 3 SURGICAL LIGHT;TRUVIDIA
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.