FDA Device recall Z-1109-2025
IntelliVue Patient Monitor MX500
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of IntelliVue Patient Monitor MX500 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-1109-2025 |
| 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 MX500. Model Number: 866064
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: 866064. UDI-DI: (01)00884838038776(21); Serial Numbers: DE7580A1R5, DE7580A1R4, DE7580A1R1, DE7580A1R0, D…Model Number: 866064. UDI-DI: (01)00884838038776(21); Serial Numbers: DE7580A1R5, DE7580A1R4, DE7580A1R1, DE7580A1R0, DE7580A1PM, DE7580A1PL, DE7580A1PK, DE7580A1PJ, DE7580A1P5, DE351C8913, DE351C8912, DE351C8908, DE351C8911, DE351C8910, DE351C8909, DE32300881, DE32300882, DE32300883, DE32300937, DE32300936, DE32301099, DE35114607, DE35114606, DE671T0786, DE671K1669, DE671V9213, DE35133301, DE671N0625, DE671E0967, DE671E0964, DE671E0965, DE671E0968, DE671E0978, DE671E1009, DE671E1008, DE671E1007, DE671E1006, DE671E1005, DE671E1004, DE671E0977, DE671E1003, DE671E0979, DE671E1015, DE671E0966, DE671E1059. |
|---|
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-1109-2025%22
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