🔍 RecallPedia

IntelliVue Patient Monitor MX450. Model Number: 866062

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: 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, DE7770D6LE, DE35142704, DE35142703, DE35142705, DE35142702, DE35142706, DE35182894, DE32301491, DE32301476, DE32301477, DE32301478, DE32301479, DE32301480, DE32301481, DE32301482, DE32301483, DE32301484, DE32301485, DE32301486, DE32301487, DE32301488, DE32301489, DE32301490, DE32301506.
  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 MX450. Model Number: 866062

Product Codes/Lot Numbers:

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, DE7770D6LE, DE35142704, DE35142703, DE35142705, DE35142702, DE35142706, DE35182894, DE32301491, DE32301476, DE32301477, DE32301478, DE32301479, DE32301480, DE32301481, DE32301482, DE32301483, DE32301484, DE32301485, DE32301486, DE32301487, DE32301488, DE32301489, DE32301490, DE32301506.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1108-2025

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