Patient Information Center iX recallZ-2608-2023 · Philips North America Llc · initiated Aug 17, 2023

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-2608-2023

Recall class

Class II

Status

Open, Classified

Initiated by the company

Aug 17, 2023

Posted by the FDA

Sep 19, 2023

Recalling firm

Philips North America Llc

Quantity

960 units

Product code

MHX

FDA submissions

K153702

Distribution

Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark Finland France Germany Greece India Ireland Italy Japan Jordan Kenya Kuwait Lebanon Lithuania Netherlands Norway Poland Portugal Qatar Romania Slovakia South Africa South Korea Spain Sweden Sweden Switzerland United Kingdom Utd.Arab.Emir. Uzbekistan

Product description

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Patient Information Center iX

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  4 recalls2 deaths24 reports
• Patient Information Center iX

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  3 recalls3 deaths11 reports

Product lines

• Patient Information Center iXPhilips Medizin Systeme Böblingen GmbH · 9 models · 406 reports · 7 recalls