Recall Z-0020-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
| Date | Oct 4, 2024 (initiated Jun 14, 2023) |
| Status | Open, Classified |
| Reason | Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23. |
| Root cause | Process control |
| Action | PHILIPS issued Urgent Field Safety Notice (2023-CC-HPM-019) on 6/14/23. Letter states reason for recall, health risk and action to take: " Please be aware that without Option C01 (Full Arrhythmia) the device will not provide the yellow alarms for enhanced arrhythmia detection. " Review the contents of this letter with your staff. " Pass this notice to all those who need to be aware within your organization or to any organization where the affected devices might have been transferred. 5. Actions taken by Philips to correct the problem Philips Representative will contact you to arrange reload of |
| Quantity | 153 units OUS |
| Distribution | Foreign Only: Denmark France Germany Japan United Kingdom |
| FDA record | Open on fda.gov |