FDA Device recall Z-1110-2025
IntelliVue Patient Monitor MX550
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of IntelliVue Patient Monitor MX550 by Philips North America, citing potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1110-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-15 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | FL, NC |
Product
IntelliVue Patient Monitor MX550. Model Number: 866066
Reason
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Identifiers
| code_info | Model Number: 866066. UDI-DI: (01)00884838038783(21); Serial Numbers: DE671E3020, DE671E2989, DE671E2988, DE671E3086, D…Model Number: 866066. UDI-DI: (01)00884838038783(21); Serial Numbers: DE671E3020, DE671E2989, DE671E2988, DE671E3086, DE671E3085, DE671E3084, DE671E3097, DE671E3096, DE671E3095, DE671E3094, DE671E3093, DE671E3253, DE671E3246, DE671E3245, DE671E3244, DE671E3241, DE671E3240, DE671E3234, DE671E3235, DE671E3238, DE671E3239, DE671E3021, DE671E3236, DE671E3865, DE671E3863, DE671E3862, DE671E3861, DE671E3860, DE671E3859, DE671E3858, DE671E3857, DE671E3856, DE671E3855, DE671E3853, DE671E3852, DE671E3867, DE671E3871, DE671E3730, DE671E3729, DE671E3866, DE35186967, DE35186949, DE35186948, DE35186947, DE35186944, DE35186943, DE35186942, DE35186941, DE35186940, DE35186939, DE35186938, DE35186982, DE35186945, DE35199396, DE35199398, DE35199428, DE671E2030, DE671H1334, DE32302561, DE32302562, DE32301002, DE32301003, DE32301004, DE35114609, DE35114608, DE758Y7635, DE758Y7616, DE758Y7619, DE758Y7615, DE758Y7614, DE7580AWK6, DE7580AWK7, DE7580AWKB, DE7580AWK4. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2025%22
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