Device Recall Spacelabs Healthcare Pathfinder SL Holter Analyzer

  • Modelo / Serial
    Version 1.6.0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.
  • Descripción del producto
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. || Product Usage: || The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA