Z-2608-2023Class II

Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information...

Name: Z-2608-2023 Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information...
Creator: Philips North America Llc
Published: 2023-08-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-08-17 / Open, Classified

FDA source

Philips North America Llc began a recall of Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient... on 2023-08-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2608-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-17
Posted: 2023-09-19
Recalling firm: Philips North America LLC
Product: 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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 960 units
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 codes and lots: UDI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 Software Version Number 4.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2608-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2608-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19

Product code MHX

K153702Class IIM3290B Philips IntelliVue Information Center iXPhilips Medical Systems / cleared 2016-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)