Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER

  • Model / Serial
    Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
  • Product Description
    Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style || Catalog #: 6480-25. || The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Dixtal Medical, Inc., 101 N Plains Industrial Rd Bldg 2, Wallingford CT 06492-2360
  • Manufacturer Parent Company (2017)
  • Source
    USFDA