Devices

Device Recall BK Medical ApS Ultrasound System Scanner

  • Modelo / Serial
    Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
  • Descripción del producto
    BK Medical ApS Ultrasound System Scanner bk2300 - || Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. || The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
  • Manufacturer
    B-K Medical A/S
  • 1 Event

Fabricante

B-K Medical A/S
  • Dirección del fabricante
    B-K Medical A/S, Mileparken 34, Herlev Denmark
  • Empresa matriz del fabricante (2017)
    Bk Medical Holding Aps
  • Source
    USFDA