Philips North America (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Brand
Philips North America
Lot Codes / Batch Numbers
UDI-DI: (1) 00884838104594 (2) 00884838112070 (3) 00884838121782 Software: PIC iX Version 4.X
Products Sold
UDI-DI: (1) 00884838104594 (2) 00884838112070 (3) 00884838121782 Software: PIC iX Version 4.X
Philips North America is recalling (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model due to Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Recommended Action
Per FDA guidance
On November 28, 2023, the firm notified affected consignees through URGENT Medical Device Correction letters. This failure is applicable to Apple iOS devices only. If customers use iOS devices (e.g. iPhone, iPad, etc.) to receive event notifications: 1) Please conduct patient monitoring at the central station or patient bedside. 2) Please do not use iOS event notifications for patient monitoring. A Philips representative will contact you to schedule a visit to install a software patch to your device which will correct the current issue. Patch PIC iX 4.2.2 will be provided for PIC iX 4.X and patch CareEvent C.03.07 will be provided for CareEvent C.03.X. If you need any further information, please contact your local Philips representative, or call 1-800-722- 9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026