Device recall
Z-2166-2010: The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be…
FDA device recall · Class II · Zoe Medical Incorporated
Key facts
| Recall number (Z-number) | Z-2166-2010 |
|---|---|
| Recall event | 55507 |
| 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 |
| Recalling firm | Zoe Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2010 |
| 510(k) numbers | K040012 |
| FEI number | 3003294644 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database