Device Recall Shape Disposable Patient Interface

  • Modèle / numéro de série
    Lot Numbers: 1412001, 1412002, 1412003 and 1412004
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
  • Société-mère du fabricant (2017)
  • Source
    USFDA