Events

Rappel de Device Recall Medtronic Oarm O2 Imaging System

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
    73303
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1088-2016
  • Date de mise en oeuvre de l'événement
    2016-01-29
  • Date de publication de l'événement
    2016-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143801
  • 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
    Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 imaging system, causing noise and vibration when being positioned or during 3d imaging could lead to poor image quality.
  • Action
    Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.

Device

Device Recall Medtronic Oarm O2 Imaging System
  • Modèle / numéro de série
    Serial Number: C0936
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to Austria only.
  • Description du dispositif
    Medtronic 0-arm 02 Imaging System || Catalog Number: Bl-700-02000 || The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. || The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Adresse du fabricant
    Medtronic Navigation, Inc., 300 Foster St, 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