Device recall
Z-0206-2012: LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated…
FDA device recall · Class II · Lifewatch Services Inc
Key facts
| Recall number (Z-number) | Z-0206-2012 |
|---|---|
| Recall event | 59990 |
| Product | LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel 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 Card Guard, 2 Pekeris St… |
| Product code | DXH |
| Recalling firm | Lifewatch Services Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2012 |
| 510(k) numbers | K071995, K101639 |
| 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