Ellipse VR/DR

  • Modèle / numéro de série
    CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C, -36QC) | All
  • Description du dispositif
    AIMD: Implant, cardiac pacemaker
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • 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
    SATP

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Active implantable medical devices - defibrillators
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
  • Manufacturer
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Active implant
  • Manufacturer
  • Modèle / numéro de série
    St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822
  • Classification du dispositif
  • Manufacturer
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