Recall Z-1315-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
IntelliVue X3 Patient Monitor.
| Date | Apr 6, 2018 (initiated Nov 17, 2017) |
| Status | Terminated |
| Reason | The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface. |
| Root cause | Under Investigation by firm |
| Action | Philips will contact customers with affected devices to arrange a correction of the issues. Firm plans a Software update of the affected devices and Replacement of the display assembly. |
| Quantity | 975 (updated 8-14-18) |
| Distribution | 48 Foreign Accounts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extensio Philips Medizin Systeme Boeblingen GmbH, Oct 6, 2017 |