Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier

  • Modèle / numéro de série
    Model number DV5HH, serial number range from HH073341 to HH077139.  Model number DV51D-HH, serial number range from ID022837 to ID023117.  Model number DV53-HH, serial number range from JD004065 to JD004224.  Model number DV54D-HH, serial number range from HD023473 to HD024014.  Model number DV55D-HH, serial number range from KD005598 to KD005695.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution; USA (nationwide) including states of AL, AR, CA, FL, IL, IN, IA, KS, KY, MD, MA, MI, MS, NE, NJ, NY, OH, PA, WA, WV, and WI; and countries of Europe.
  • Description du dispositif
    DeVilbiss Model DV5x Series CPAP with Heated Humidifier || Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sunrise Medical HHG Inc. dba DeVilbiss Healthcare, 100 DeVilbiss Drive, Somerset PA 15501-2125
  • Source
    USFDA