Recall StatusOpen, Classified
Date Initiated2023-08-17
Product Quantity960 units
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
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.