Device recall
Z-0284-2021: Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-0284-2021 |
|---|---|
| Recall event | 86441 |
| Product | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to… |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2022 |
| 510(k) numbers | K031187 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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