Events

Rappel de Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Navigation, 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
    65743
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1956-2013
  • Date de mise en oeuvre de l'événement
    2013-07-15
  • Date de publication de l'événement
    2013-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120018
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Neurological stereotaxic Instrument - Product Code HAW
  • Cause
    Medtronic navigation, inc. has initiated a field correction to their framelink software version 5.4 which can be used on medtronic navigation stealthstation 57 and i7 systems or a medtronic planning station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
  • Action
    A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.

Device

Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM
  • Modèle / numéro de série
    Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    StealthStation S7 Framelink Software version 5.4. || Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Adresse du fabricant
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • 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
    USFDA