Manufacturers

Shape Medical Systems, Inc

2 dispositivos en la base de datos

Device Recall Shape HF Cardiopulmonary System
  • Modelo / Serial
    DPIs with Lot Number 1405006 and higher.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
Device Recall Shape Disposable Patient Interface
  • Modelo / Serial
    Lot Numbers: 1412001, 1412002, 1412003 and 1412004
  • Clasificación del producto
    Anesthesiology Devices
  • 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.