Device recall
Z-2495-2019: Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2495-2019 |
|---|---|
| Recall event | 83560 |
| Product | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration |
| Product code | DSA |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2020 |
| 510(k) numbers | K110287 |
| FEI number | 1218950 |
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