Recall Z-1386-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
| Date | Mar 27, 2024 (initiated Feb 28, 2024) |
| Status | Open, Classified |
| Reason | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction dated 2/27/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 1. The Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status. 2. Customers should update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affectin |
| Quantity | 257,183 Units |
| Distribution | Worldwide - US Nationwide distribution. |
| 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 |