FDA Medical Device Recalls (openFDA)
Zoe Medical Incorporated: 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.
- Recall number
- Z-2166-2010
- Recalling firm
- Zoe Medical Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2009-02-02
- Posted
- 2010-08-03
- Terminated
- 2010-08-03
- Reason
- Touch panel may become unresponsive.
- 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
- 62
- Distribution
- Nationwide Distribution -- MA and MD.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K040012"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 3003294644
- Firm city
- Topsfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28