Medical device recalls Moderate risk

Philips North America recalls Patient Information Center iX; Software Version Number: 4.5.0

Recall date
December 22, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1156-2026
FDA classification
Class II
Brand / firm
Philips North America
Sold / distributed
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, Switze…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Patient Information Center iX; Software Version Number: 4.5.0

Get recall alerts

Free email alert whenever Philips North America has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Philips North America