ClearanceBrief
Recall Z-1156-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Philips North America

Patient Information Center iX; Software Version Number: 4.5.0

DateJan 22, 2026 (initiated Dec 22, 2025)
StatusOpen, Classified
ReasonA recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Root causeSoftware Design Change
ActionOn 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 sys
Quantity146 units (41 US, 105 OUS)
DistributionWorldwide 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, Switzer
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K153702M3290B Philips IntelliVue Information Center iX
Philips Medical Systems, Jun 13, 2016