Device recall
Z-1345-2020: Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1345-2020 |
|---|---|
| Recall event | 84879 |
| Product | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171… |
| Product code | MWJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2023 |
| 510(k) numbers | K071733 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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