FDA-Device2012-09-26Class II
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.
Zoe Medical Incorporated
Hazard
Unit fails to power up, resulting in an equipment alarm
Sold states
Nationwide distribution: WA only.
Affected count
35 units
Manufactured in
460 Boston St, Topsfield, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2380-2012Don't want to check this manually?
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