FDA Device recall Z-1108-2025

IntelliVue Patient Monitor MX450

FDA Device
Class II
ongoing
Published 2025-02-12

On 2025-02-12 the FDA classified a Class II recall of IntelliVue Patient Monitor MX450 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-1108-2025
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 MX450. Model Number: 866062

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: 866062. UDI-DI: (01)00884838038769(21); Serial Numbers: DE35169761, DE671V3903, DE671V3885, DE671V7898, D… Model Number: 866062. UDI-DI: (01)00884838038769(21); Serial Numbers: DE35169761, DE671V3903, DE671V3885, DE671V7898, DE7770DC1L. UDI-DI: 884838045859; Serial Numbers: DE32303399, DE32302479, DE32302480, DE32306956, DE35131294, DE35114613, DE35114612, DE671T9641, DE7770C86L, DE7770C86K, DE7770C86J, DE7770C86H, DE7770C86G, DE35120431, DE671K3731, DE671K3729, DE671K3706, DE671K3796, DE671K3816, DE671K3737, DE671K3773, DE671L0436, DE671L0462, DE671L0406, DE671L5214, DE671L5207, DE671L5206, DE671L5181, DE671L5169, DE671M3993, DE671M4048, DE671M4036, DE671M4037, DE671M4053, DE671M7009, DE671M7012, DE671M9968, DE671M9972, DE671M9963, DE671N0009, DE671N0010, DE671N0092, DE671N0008, DE671N0001, DE671N0002, DE671M9985, DE671M9999, DE671N0000, DE671P0411, DE671P1094, DE671P2457, DE671P2537, DE32306016, DE32306017, DE32306018, DE7580B4PC, DE7580B4PB, DE7580B4PA, DE7770C6ZP, DE7770C74Y, DE7770C74Z, DE7770C750, DE7770C74W, DE7770C74V, DE7770C78E, DE7770C78D, DE7770D6LH, DE7770D6LG, DE7770D6LF, DE77

code_info

Model Number: 866062. UDI-DI: (01)00884838038769(21); Serial Numbers: DE35169761, DE671V3903, DE671V3885, DE671V7898, D…

Model Number: 866062. UDI-DI: (01)00884838038769(21); Serial Numbers: DE35169761, DE671V3903, DE671V3885, DE671V7898, DE7770DC1L. UDI-DI: 884838045859; Serial Numbers: DE32303399, DE32302479, DE32302480, DE32306956, DE35131294, DE35114613, DE35114612, DE671T9641, DE7770C86L, DE7770C86K, DE7770C86J, DE7770C86H, DE7770C86G, DE35120431, DE671K3731, DE671K3729, DE671K3706, DE671K3796, DE671K3816, DE671K3737, DE671K3773, DE671L0436, DE671L0462, DE671L0406, DE671L5214, DE671L5207, DE671L5206, DE671L5181, DE671L5169, DE671M3993, DE671M4048, DE671M4036, DE671M4037, DE671M4053, DE671M7009, DE671M7012, DE671M9968, DE671M9972, DE671M9963, DE671N0009, DE671N0010, DE671N0092, DE671N0008, DE671N0001, DE671N0002, DE671M9985, DE671M9999, DE671N0000, DE671P0411, DE671P1094, DE671P2457, DE671P2537, DE32306016, DE32306017, DE32306018, DE7580B4PC, DE7580B4PB, DE7580B4PA, DE7770C6ZP, DE7770C74Y, DE7770C74Z, DE7770C750, DE7770C74W, DE7770C74V, DE7770C78E, DE7770C78D, DE7770D6LH, DE7770D6LG, DE7770D6LF, DE77

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-1108-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.