SQ-RX 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
    SATP

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    All SQ-RX Model 1010 Pulse Generators are affected and approximately 9,000 remain in service. This PG is no longer available for implantation and any remaining inventory is expired.
  • Description du dispositif
    Active Implantable Device
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert over certain Cameron pulse generators
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert over Cameron Health SQ-RX Pulse Generators
  • Manufacturer