Device recall
Z-1671-2021: IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-1671-2021 |
|---|---|
| Recall event | 87829 |
| Product | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport… |
| Product code | DSI |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2022 |
| 510(k) numbers | K113125 |
| FEI number | 3016618143 |
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