FDA Recall: Software patch notification error

Company: Phillips North America
Date of Enforcement Report: 01/22/2026
Class: II

PRODUCT:

Patient Information Center iX; Software Version Number: 4.5.0

Recall Number:

Z-1156-2026

REASON:

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

RECALLING FIRM/MANUFACTURER:

Philips North America

VOLUME:

146 units (41 US, 105 OUS)

DISTRIBUTION:

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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