Patient Information Center iX; Software Version Number: 4.5.0
FDA device recall Z-1156-2026 · posted 2026-01-22 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 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, Net
- Date initiated
- 2025-12-22
- Date posted
- 2026-01-22
- Location
- Cambridge, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |