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U.S. Department of Health and Human Services

Class 2 Device Recall WellHome Monitor

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 Class 2 Recall
WellHome Monitor
see related information
Date Posted August 03, 2010
Recall Status1 Terminated on August 03, 2010
Recall Number Z-2166-2010
Recall Event ID 55507
Premarket Notification
510(K) Number
K040012 
Product Classification System, Measurement, Blood-Pressure, Non-Invasive - Product Code DXN
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Zoe Medical Incorporated
460 Boston St
Topsfield, Massachusetts 01983-1223
For Additional Information Contact James Chickering
978-887-1410
Manufacturer Reason
for Recall
Touch panel may become unresponsive.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.
Quantity in Commerce 62
Distribution Nationwide Distribution -- MA and MD.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = ZOE MEDICAL, INC.
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