International Medical Devices Database

Manufacturer Address
Zoe Medical Incorporated, 460 Boston St, Topsfield MA 01983-1223
Manufacturer Parent Company (2017)
Zoe Medical Incorporated
Source
USFDA
2 Events
- Recall of Device Recall WellHome Monitor
- Recall of Device Recall Ultraview DM3 Monitor

2 devices in the database

Device Recall WellHome Monitor

Model / Serial
Serial numbers WFD5373, WFD5374, WFD5375, WFD5376, WFD5377, WFD5378, WFD5379,WFD5380, WFD5381, WFD5382, WFD5383, WFD5384, WFD5385, WFD5386, WFD5387, WFD5388, WFD5389, WFD5390, WFD5392, WFD5393, WFD5394,WFD5395, WFD5396, WFD5398, WFD5399, WFD5400, WFD5401, WFD5402, WFD5403, WFD5404, WFD5405, WFD5406, WFD5407, WFD5408, WFD5409,WFD5410, WFD5411, WFD5412, WFD5413, WFD5414, WFD5415, WFD5416, WFD5417, WFD5418, WFD5419, WFD5420, WFD5421, WFD5422, WFD5423,\/VFD5424, VVFD5425, WFD5426, WFD5427, WFD5428, WFD5429, WFD5431, WFD5432, WFD5435, WFD5436, WFD5437, WFD5438, and WFD5439.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- MA and MD.
Product Description
The Well@Home Monitor by Patient Care technologies || Model 179-2150 || Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.

Device Recall Ultraview DM3 Monitor

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: WA only.
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.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Zoe Medical Incorporated

2 devices in the database

Device Recall WellHome Monitor

Device Recall Ultraview DM3 Monitor