Device recall
Z-0208-2012: ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry…
FDA device recall · Class II · Lifewatch Services Inc
Key facts
| Recall number (Z-number) | Z-0208-2012 |
|---|---|
| Recall event | 59990 |
| Product | ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by… |
| Product code | DXH |
| Recalling firm | Lifewatch Services Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2012 |
| 510(k) numbers | K071995, K081257, K101639, K110499 |
| FEI number | 1000127138 |
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