EMBLEM S-ICD Pulse Generator

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NZMMDSA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Model Catalog: A209 (Lot serial: all); Model Catalog: 1010 (Lot serial: all); Model Catalog: A219 (Lot serial: all); Model Catalog: 3200 (Lot serial: ALL)
  • Description du dispositif
    EMBLEM S-ICD PULSE GENERATOR;SICD SYSTEM - SQ-RX PULSE GENERATOR;EMBLEM MRI S-ICD PG;SICD SYSTEM - Q-TECH PROGRAMMER
  • Manufacturer