Device Recall Infinity Delta Portable Patient Monitor

  • Model / Serial
    Catalog Number(s): MS18597/MS18852 with serial numbers (US): 6001227774, 6001229772, 6001083376, 6001100483, 6001191277, 6001193373, 6001272680, 6001263779, 6001233678, 6001281679, 6001306582, 6001078774, 6001238370, 6001212879, 6001282972, 6001285969, 6001296369, 6001296467, 6001267374, 6001316580, 6001103186, 6001282776, 6001233580, 6001242579, 6001246174, 6001267472, 6001465775, 6001093775, 6001219774, 6001230476, 6001234873, and 6001235676.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Infinity Delta 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

Manufacturer

  • Manufacturer Address
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
  • Source
    USFDA