Events

Rappel de ALLURA XPER FD10/10 - MAIN UNIT

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

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
    143084
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-28
  • 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
    Philips has become aware that extra monitors so called 7th or 8th monitor mounted on the monitor ceiling suspension (mcs) might disengage from the mcs and fall down. the two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. if the set screws have come loose gravity can keep the rods in position. however if a force is exerted on the monitor pushing it forward the monitor can topple forward. once the monitor has toppled over it is only attached with its wires. if the monitor breaks loose of its wires it will drop on the floor. see e-file for french translation.

Device

ALLURA XPER FD10/10 - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/20 (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20 (Lot serial: N/A); Model Catalog: 000454 (Lot serial: N/A)
  • Description du dispositif
    ALLURA XPER FD10/10 - MAIN UNIT;ALLURA XPER FD20/10 SYSTEM-MAIN UNIT;ALLURA XPER FD20/20;ALLURA XPER FD10;ALLURA XPER FD20 SYSTEM - MAIN UNIT;ALLURA XPER FD20 OR TABLE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC