Device Recall Fukuda Denshi patient monitor

  • Model / Serial
    50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
  • Product Description
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. || The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is || meant to acquire and monitor physiological signals from patients.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Fukuda Denshi USA, Inc., 17725 NE 65th St Ste C, Redmond WA 98052-4911
  • Manufacturer Parent Company (2017)
  • Source
    USFDA