Philips North America Llc Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154 Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients

Recommended Action

Per FDA guidance

Philips issued Urgent field Safety Notice to to U.S. customers via certified mail on 8/17/23. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: If central monitoring is disrupted and blank screen displays: 1) Initiate local downtime procedures to evaluate patients at bedside and confirm local monitoring devices continue to monitor. 2) Manually reboot PIC iX to continue central monitoring This notice should be passed on to all those who need to be aware within your organization or to any organization where PIC iX 4.x devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will install a software patch to your device. The patch will add defensive mitigations to force an automatic resumption of central patient monitoring without manual intervention. If central monitoring is disrupted and blank screen displays: 1) Initiate local downtime procedures to evaluate patients at bedside and confirm local monitoring devices continue to monitor. 2) Manually reboot PIC iX to continue central monitoring This notice should be passed on to all those who need to be aware within your organization or to any organization where PIC iX 4.x devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will install a software patch to your device. The patch will add defensive mitigations to force an automatic resumption of central patient monitoring without manual intervention. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377.