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Devices
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.
Manufacturer
Zoe Medical Incorporated
1 Event
Recall of Device Recall WellHome Monitor
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Manufacturer
Zoe Medical Incorporated
Manufacturer Address
Zoe Medical Incorporated, 460 Boston St, Topsfield MA 01983-1223
Manufacturer Parent Company (2017)
Zoe Medical Incorporated
Source
USFDA
Language
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