Events

Rappel de STEALTHSTATION S7 - SOFTWARE CRANIAL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA 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
    62344
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-07-15
  • 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
    Medtronic navigation inc. has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the look-ahead view labels to show user selected depths (displayed) but the corresponding images are shown at a depth twice the selected distance. under these conditions visualization of the planned trajectory could show the image at the incorrect depth. medtronic navigation inc. has received three customer reports related to this issue. none of the reports cited any patient injuries or adverse events. this corrective action covers only version 5.4 of this software. earlier versions of the framelink software are not included in this action.

Device

STEALTHSTATION S7 - SOFTWARE CRANIAL
  • Modèle / numéro de série
    Model Catalog: 9733986 (Lot serial: All lots contact mfg)
  • Description du dispositif
    Medtronic Navigation StealthStationr S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC