Device Recall FFR LinkFFR Signal Processing Module

  • Modelo / Serial
    Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to one customer in Missouri.
  • Descripción del producto
    FFR Link-FFR Signal Processing Module, Material Number H7495551000 || It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
    USFDA