Events

Rappel de Device Recall Medtronic Navigation Oarm 02

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.-Littleton.

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
    74158
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2083-2016
  • Date de mise en oeuvre de l'événement
    2016-03-17
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146536
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    Review of on-system electronic product labeling and instr uctions for use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21cfr part 1 020.30(h).
  • Action
    Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.

Device

Device Recall Medtronic Navigation Oarm 02
  • Modèle / numéro de série
    model number BT-700-02000
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Medtronic Navigation O-arm 02 surgical x-ray imaging system
  • Manufacturer
    Medtronic Navigation, Inc.-Littleton

Manufacturer

Medtronic Navigation, Inc.-Littleton
  • Adresse du fabricant
    Medtronic Navigation, Inc.-Littleton, 300 Foster Street, Littleton MA 01460-2017
  • 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