Z-2166-2010

The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for...

Name: Z-2166-2010 The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for...
Creator: Zoe Medical Incorporated
Published: 2009-02-02
License: https://open.fda.gov/license/

Zoe Medical, Inc. / initiated 2009-02-02 / Terminated

FDA source

Zoe Medical Incorporated began a recall of 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... on 2009-02-02. The reason FDA records is "Touch panel may become unresponsive". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2166-2010
Status: Terminated
Initiated: 2009-02-02
Posted: 2010-08-03
Terminated: 2010-08-03
Recalling firm: Zoe Medical, Inc.
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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Touch panel may become unresponsive.
FDA root cause: 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.
Product codes and lots: 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 code DXN

K040012Class IIWell@home SystemZoe Medical, Inc. / cleared 2004-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)