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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

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.
Recall Number Z-2380-2012
Classification Class II
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
Product Distributed Qty 35 units
Reason For Recall Unit fails to power up, resulting in an equipment alarm

Event Detail

Event Id 62939
Product Type Devices
Status Terminated
Recalling Firm Zoe Medical Incorporated
City Topsfield
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: WA only.