Recall Z-2166-2010 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
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.
| Date | Aug 3, 2010 (initiated Feb 2, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040012 | WELL@HOME SYSTEM Zoe Medical, Inc., Apr 2, 2004 |