Events

Rappel de cardioverter defibrillators and cardiac resynchronization therapy defibrillators

Selon Republic of Lebanon Ministry of Public Health, ce/cet/cette rappel concerne un dispositif en/au/aux/à Lebanon qui a été fabriqué par St. Jude.

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

Device

cardioverter defibrillators and cardiac resynchronization therapy defibrillators
  • Modèle / numéro de série
  • Manufacturer
    St. Jude

Manufacturer

St. Jude
  • 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.
  • Représentant du fabricant
    Basic Trading sarl
  • Source
    RLMPH