• Modelo / Serial
    Model Catalog: 77513-104 (Lot serial: 1201120 1201206 1201104); Model Catalog: 77513-104 (Lot serial: S/NS 121069 1201112); Model Catalog: 77513-104 (Lot serial: 1201713 120119 1201109); Model Catalog: 08C89-01 (Lot serial: ALL S/NS); Model Catalog: 77513-104 (Lot serial: 1201284 1201197 1201251); Model Catalog: 77513-104 (Lot serial: 1201435 1201438 1201439); Model Catalog: 77513-104 (Lot serial: 1201715.)
  • Descripción del producto
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
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