Patient Information Center iX; Software Version Number: 4.5.0
FDA Recall Z-1156-2026 · Posted 2026-01-22
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Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-12-22
Product Quantity146 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.
Firm Action
On or about December 22, 2025 URGENT Medical Device Correction letters were sent to customers.
Actions to be taken:
Review the Mobile Notification Event Filters settings and confirm all the events intended to be sent
to mobile devices automatically are enabled for Mobile Notification Event Filters.
" Pass this notice to all those who need to be aware within your organization or to any organization
where affected product(s) have been potentially transferred.
Actions planned by Philips to correct the problem
" Philips representative will contact you to obtain PIC iX 4.5.1 SW patch for PIC iX systems running
software version 4.5.0.
If you need any further information, please contact your local Philips representative, or call (800) 722-9377.
Root Cause
Software Design Change
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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