Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1109-2025 — IntelliVue Patient Monitor MX500. Model Number: 866064

U.S. FDA — Device Enforcement · United States · 2025-01-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1109-2025
Date of alert
2025-01-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838038776
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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