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U.S. Department of Health and Human Services

Class 2 Device Recall WellHome Monitor

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 Class 2 Device Recall WellHome Monitorsee related information
Date Initiated by FirmFebruary 02, 2009
Date PostedAugust 03, 2010
Recall Status1 Terminated 3 on August 03, 2010
Recall NumberZ-2166-2010
Recall Event ID 55507
510(K)NumberK040012 
Product Classification Non-Invasive Blood Pressure Measurement System - Product Code DXN
ProductThe 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 MA 01983-1223
For Additional Information ContactJames Chickering
978-887-1410
Manufacturer Reason
for Recall		Touch panel may become unresponsive.
FDA Determined
Cause 2		Component change control
ActionZoe 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 Commerce62
DistributionNationwide Distribution -- MA and MD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXN
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