Philips North America: Device Recall

Recall Details

Recall Number

Z-3249-2024

Classification

Class II

Product Type

Device

Recalling Firm

Philips North America

Status

Ongoing

Date Initiated

08/30/2024

Location

Cambridge, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

545 devices

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.

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)

Distribution Pattern

US Nationwide. Global Distribution.

Other Recalls by Philips North America

• Class II: Risk 12/22/2025
  A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
• Class II: Risk 12/03/2025
  The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

View all recalls by Philips North America →