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.
This recall has been terminated (originally issued September 14, 2012).
- Company
- Zoe Medical Incorporated
- Recall Initiated
- June 6, 2012
- Posted
- September 14, 2012
- Terminated
- September 18, 2012
- Recall Number
- Z-2380-2012
- Quantity
- 35 units
- Firm Location
- Topsfield, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Unit fails to power up, resulting in an equipment alarm
Distribution
Nationwide distribution: WA only.
Lot / Code Info
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
Root Cause
Software design
Action Taken
The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.