Events

Rappel de FLOOR MOUNTING COLUMN JUPITER U

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
    26971
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-23
  • 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
    Manufacturer has become aware of unintended movement occurring during surgical cases due to the use of damaged remotes. no patients or users have been injured. there is a possibility that damage can occur to a remote control which breaks the button and can cause permanent or sporadic electrical conduction and trigger unintended movement. this is a rare event and can be avoided by proper handling and maintenance of the remote control. the product is safe as long as it is not damaged.

Device

FLOOR MOUNTING COLUMN JUPITER U
  • Modèle / numéro de série
    Model Catalog: 1276277 (Lot serial: All Lots); Model Catalog: 4500112 (Lot serial: All Lots); Model Catalog: 4500113 (Lot serial: All Lots); Model Catalog: 1574977 (Lot serial: All Lots); Model Catalog: 4500170 (Lot serial: All Lots); Model Catalog: 1389826 (Lot serial: All Lots); Model Catalog: 1622774 (Lot serial: All Lots); Model Catalog: 1223188 (Lot serial: All Lots); Model Catalog: 1389824 (Lot serial: All Lots)
  • Description du dispositif
    FLOOR MOUNTING COLUMN JUPITER U
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.