Maestro Cardiac Ablation System

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
    DMA

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    Model Number: Maestro 4000 Footswitch: M004218500- Maestro 4000 Footswitch M00421850D0- Maestro 4000 Footswitch, Demo M00421850H0- Maestro 4000 Footswitch, Hospital Owned M00421850R0- Maestro 4000 Footswitch, Repaired M00421850Z0- Maestro 4000 Footswitch, Zero Cost Maestro Pump to Generator Cable: M004315000- Cable OI Pump to OI Maestro Maestro 4000 Controller: M00440000- Maestro 4000 Controller M0044000D0- Maestro 4000 Controller, Demo M0044000H0- Maestro 4000 Controller, Hospital Owned M0044000R0- Maestro 4000 Controller, Repaired M0044000Z0- Maestro 4000 Controller, Zero Cost
  • Description du dispositif
    Electromechanical medical devices
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Boston Scientific: Maestro Cardiac Ablation System
  • Manufacturer