Implantable cardioverter defibrillators (ICDs)

  • Modèle / numéro de série
  • Description du dispositif
    St Jude Medical implantable cardioverter defibrillators (ICDs):Atlas DR model: V-242     Atlas Plus DR/VR/HF models: V-243, V-193, V-193C, V-340, V-341, V-343     Epic DR/HF models: V-233, V-337, V-338     Epic Plus DR/VR/HF models: V-236, V-239, V-196, V-239T, V-196T, V-350
  • 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
    MHRA

15 dispositifs médicaux avec un nom similaire

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  • 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
  • Modèle / numéro de série
    RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150All model numbers affected ARTG Number (Merlin@home Remote Monitoring System): 161670
  • Manufacturer
  • Modèle / numéro de série
    Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
  • Manufacturer
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