Home / Recalls / Zoe Medical Incorporated / Z-2380-2012

Z-2380-2012 Class II Terminated

Recalled by Zoe Medical Incorporated — Topsfield, MA

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