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Recall Observatory FDA recall evidence

Device product

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.

Z-2380-2012

June 06, 2012

Class II

Product summary

Firm
Zoe Medical Incorporated
Event
Event 62939
Status
Terminated
Classification
Class II
Quantity
35 units
Official record key
device-enforcement:Z-2380-2012

Official wording

Reason: Unit fails to power up, resulting in an equipment alarm

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

Distribution pattern: Nationwide distribution: WA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unit fails to power up, resulting in an equipment alarm