Events

Rappel de Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0

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 St Jude Medical Cardiac Rhythm Management Division.

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
    70066
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0949-2015
  • Date de mise en oeuvre de l'événement
    2014-12-18
  • Date de publication de l'événement
    2015-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132201
  • 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
    Pulse generator, permanent, implantable - Product Code NVZ
  • Cause
    Transmitter may initiate a software reset resulting in backup operation in some implanted st. jude medical radio frequency (rf) enabled implantable cardioverter assura, unify assura, and quadra assura icds and assurity and allure pacemakers.
  • Action
    The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.

Device

Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions ...
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
  • Description du dispositif
    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. || Usage:RF Remote Transmitter
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division

Manufacturer

St Jude Medical Cardiac Rhythm Management Division
  • Adresse du fabricant
    St Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA