Device recall
Z-0020-2025: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-0020-2025 |
|---|---|
| Recall event | 95324 |
| Product | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever… |
| Product code | MHX |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130849, K131872 |
| FEI number | 3016618143 |
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