Device recall
Z-1400-2012: TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By…
FDA device recall · Class II · Scottcare Corporation
Key facts
| Recall number (Z-number) | Z-1400-2012 |
|---|---|
| Recall event | 61370 |
| Product | TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously… |
| Product code | DSI |
| Recalling firm | Scottcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2013 |
| 510(k) numbers | K092947 |
| FEI number | 1527715 |
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