Philips North America: Device Recall

Recall Details

Recall Number

Z-1156-2026

Classification

Class II

Product Type

Device

Recalling Firm

Philips North America

Status

Ongoing

Date Initiated

12/22/2025

Location

Cambridge, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

146 units (41 US, 105 OUS)

Reason for Recall

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

Product Description

Patient Information Center iX; Software Version Number: 4.5.0

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.

Other Recalls by Philips North America

• 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).
• 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 →