FDA recall, , Moderate risk
Philips Patient Information Center iX
The Patient Information Center iX software can modify event notification settings without user indication.
Summary by Recall Canary from the FDA notice
What happened
Philips North America is recalling the Patient Information Center iX, Software Version Number 4.5.0, because a recent software patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. The recall affects 146 units, with 41 in the US and 105 outside the US. The company began the recall on December 22, 2025, and it was added to the FDA's Enforcement Report on January 22, 2026.
The product is distributed worldwide, including US Nationwide and countries such as Austria, Belgium, Brazil, Canada, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Patient Information Center iX; Software Version Number: 4.5.0
- UDI-DI
- 00884838127074
Recall details
- Company began the recall
- Sold in
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.
- Company
- Philips North AmericaCambridge, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98217
- Recall number
- Z-1156-2026
- Quantity recalled
- 146 units (41 US, 105 OUS)
All recalls from Philips North America
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
