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.
FDA Recall Z-2166-2010 · Posted 2010-08-03
Recalling FirmZoe Medical Incorporated
Recall StatusTerminated
Product CodeDXN
Date Initiated2009-02-02
Date Terminated2010-08-03
Product Quantity62
Reason for Recall
Touch panel may become unresponsive.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution -- MA and MD.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.