Events

Rappel de VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ORTHO-CLINICAL DIAGNOSTICS.

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
    95395
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-02-02
  • 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
    Ortho clinical diagnostics has initiated this recall notification due to a possibility of misconfigured electrical wiring in the power system on the vitros 5600 integrated system. this creates a situation where an individual module intended to be shut off will remain on if only the associated power cord is unplugged. note there are two power cords per vitros 5600 system. normal use maintenance and troubleshooting on vitros 5600 systems will not expose an operator to electrical hazards as a result of this issue. the electrical wires are located in an area that is intended to be accessed only by ortho-trained service representatives. there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros 5600 system as a whole prior to working on a component.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    VITROS 5600 Integrated System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS