Z-2380-2012 Class II Terminated
FDA device recall Z-2380-2012 was initiated by Zoe Medical Incorporated on June 6, 2012 and is designated Class II. Reason for recall: Unit fails to power up, resulting in an equipment alarm The recall status is terminated (terminated September 18, 2012). Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- June 6, 2012
- Termination Date
- September 18, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
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
Distribution Pattern
Nationwide distribution: WA only.
Code Information
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