Home / Recalls / Philips North America / Z-3249-2024

Z-3249-2024 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
August 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
545 devices

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)

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.

Distribution Pattern

US Nationwide. Global Distribution.

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.

Other recalls by Philips North America

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  • Z-1318-2026 Class II — Spectral CT 7500 on Rails; Product Code (REF): 728334; (January 7, 2026)
  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
  • Z-1033-2026 Class II — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (December 12, 2025)
  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
  • Z-1215-2026 Class II — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S (December 3, 2025)
  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)