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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 Monitor see related information
Date Initiated by Firm February 02, 2009
Date Posting Updated August 03, 2010
Recall Status1 Terminated 3 on August 03, 2010
Recall Number Z-2166-2010
Recall Event ID 55507
510(K)Number K040012  
Product Classification Non-Invasive Blood Pressure Measurement System - 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/
Zoe Medical Incorporated
460 Boston St
Topsfield MA 01983-1223
For Additional Information Contact James Chickering
Manufacturer Reason
for Recall
Touch panel may become unresponsive.
FDA Determined
Cause 2
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 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) Database 510(K)s with Product Code = DXN and Original Applicant = ZOE MEDICAL, INC.