Philips North America Llc Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Event Catalog information does not save when copied and transferred from one unit to another.

Recommended Action

Per FDA guidance

Consignees were sent an "URGENT Medical Device Correction," notification, dated 4/12/24. Consignees are instructed in the notification to review in Events Monitor and confirm the expected category is assigned for the reviewed event. If events are not assigned to the correct category consignees are not to depend on event notification for patient monitoring. The provided recall notification should be provided to all users of affected devices and to those the device was further distributed, for their awareness. Philips will contact consignees to schedule a visit from a Philips Field Service Engineer to provide a software patch (PIC iX 4.2.4) to correct the issue. Consignees with any questions are to contact their local Philips representative or call 1-800-722-9377.