Device Recall Shape Disposable Patient Interface

  • Modelo / Serial
    Lot Numbers: 1412001, 1412002, 1412003 and 1412004
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
  • Descripción del producto
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. || The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA