IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecte

FDA device recall Z-0020-2025 · posted 2024-10-04 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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.

Action taken

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 current device's software to enable missing software options (C0l, C13, C51, C54). If you need any further information, please contact your local Philips representative

Root cause

Process control

Status

Open, Classified

Product code

MHX

Quantity affected

153 units OUS

Distribution

Foreign Only: Denmark France Germany Japan United Kingdom

Date initiated

2023-06-14

Date posted

2024-10-04

Location

Cambridge, MA

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