Recall Z-2608-2023 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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
| Date | Sep 19, 2023 (initiated Aug 17, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| 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 a |
| Quantity | 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 Ut |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153702 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems, Jun 13, 2016 |