🔍 RecallPedia

IntelliVue Patient Monitor MX500. Model Number: 866064

Class I - Dangerous
🏥 Medical Devices Recalled: January 15, 2025 Philips North America Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America Llc
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

IntelliVue Patient Monitor MX500. Model Number: 866064

Product Codes/Lot Numbers:

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.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1109-2025

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