Device Recall Ultraview DM3 Monitor

  • Model / Serial
    Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: WA only.
  • Product Description
    Spacelabs Ultraview DM3 Monitor || Model Number: 91330-NT || The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zoe Medical Incorporated, 460 Boston St, Topsfield MA 01983-1223
  • Manufacturer Parent Company (2017)
  • Source
    USFDA