Events

Rappel de BRILLIANCE 6/10/16 SLICE CT SYSTEM

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
    130152
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-21
  • 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 ct system phantom supplied with certain scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm 4mm 5mm 6mm 7mm and 8mm diameters which have contrast difference of approximately 1% from aculon. the lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the ifu manual. however the pin visibility deteriorates over time usually a few years. this causes the test to become unreliable and inaccurate. to ensure that low contrast is within specification philips is providing instructions as a guideline to a more reliable check of the image noise on the water layer of the system phantom.

Device

BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Modèle / numéro de série
    Model Catalog: 4535 670 73181 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 73191 (Lot serial: N/A FOR ALL); Model Catalog: 4535 670 00121 (Lot serial: ); Model Catalog: OFF-EI-590 (Lot serial: )
  • Description du dispositif
    BRILLIANCE 6/10/16 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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