Device recall
Z-1326-2021: Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1326-2021 |
|---|---|
| Recall event | 87418 |
| Product | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086)… |
| Product code | MHX |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2023 |
| 510(k) numbers | K123900 |
| 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