Philips North America: Medical Device Recall in 2024 - (Recall #: Z-3249-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)

Product Classification:

Class II

Date Initiated: August 30, 2024

Date Posted: October 2, 2024

Recall Number: Z-3249-2024

Event ID: 95295

Reason for Recall:

During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

Status: Ongoing

Product Quantity: 545 devices

Code Information:

IntelliVue Patient Monitor MX400, 866060, UDI-DI: 00884838038752; IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562; IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769; IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776; IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783; Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated