PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 26, 2012 Initiated: June 6, 2012 #Z-2380-2012

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

Details

Recalling Firm
Zoe Medical Incorporated
Units Affected
35 units
Distribution
Nationwide distribution: WA only.
Location
Topsfield, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zoe Medical Incorporated. Units affected: 35 units.
Why was this product recalled?
Unit fails to power up, resulting in an equipment alarm
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2380-2012.