Philips North America Llc: Medical Device Recall in 2025 - (Recall #: Z-1107-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

IntelliVue Patient Monitor MX400. Model Number: 866060

Product Classification:

Class II

Date Initiated: January 15, 2025

Date Posted: February 12, 2025

Recall Number: Z-1107-2025

Event ID: 96138

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.

Status: Ongoing

Product Quantity: 28 units

Code Information:

Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H.

Distribution Pattern:

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated