Recall Z-2380-2012— Zoe Medical Incorporated
Class II · Terminated
Class II FDA medical device recall by Zoe Medical Incorporated, initiated 2012-06-06, terminated 2012-09-18. It names one FDA 510(k) clearance: K093802. Product: 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.. Reason: Unit fails to power up, resulting in an equipment alarm.
- Recalling firm
- Zoe Medical Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-06
- Terminated
- 2012-09-18
- Firm location
- Topsfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Unit fails to power up, resulting in an equipment alarm
Data sourced from openFDA. This site is unofficial and independent of the FDA.