Device Recall Gamma X XL Portable Patient Monitor

  • Modèle / numéro de série
    Catalog Number(s): MS18597/MS18852 with serial numbers (US) 6001246076, 6001246575, 6001247173, 6001365874, 6001067474, 6001073681, 6001073779, 6001073877, 6001095176, 6001098966, 6001099466, 6001069472, 6001077080, 6001198466, 6001216679, 6001229674, 6001208082, 6001211782, 6001218178, 6001220086, 6001243676, 6001246771, 6001245968, 6001357179, 6001214877, 6001075679, 6001077178, 6001083180, and 6001095773.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Georgia, Greece, Hungary, Italy, Ireland, India, Kazakhstan, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Norway, Russian Fed., Romania, Saudi Arabia, Slovakia, Spain, South Africa, Switzerland, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
  • Description du dispositif
    Infinity Gamma X XL Portable Patient Monitor. || Draeger Medical Systems, Inc. || Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Société-mère du fabricant (2017)
  • Source
    USFDA