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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00090-1
Product Name/Description Hexad 12-Lead ECG Monitoring derivation with Philips IntelliVue Patient Monitors, software versions K.21.54 or L.00.96

Affected Philips IntelliVue Measurement Modules:

Model Number: X1
Product Number: M3001A
Software Revision: K.21.54 or L.00.96

Model Number: X2
Product Number: M3002A
Software Revision: K.21.54 or L.00.96

ARTG Number: 94238
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 20/01/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the following Host Monitor configuration:

ST Analysis: “OFF”
STE Alarms: “ON”

The problem only occurs if either of the affected Philips IntelliVue Measurement Modules are used with Philips IntelliVue Patient Monitors with Hexad option #C54 (also bundled in options H11, H41, H42, CP2), or if an affected X2 Measurement Module is used in standalone mode (i.e., not connected to another monitor).

There is potential for delay in diagnosis due to the monitor not alarming for ST Elevation on the chest leads.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising users to ensure the ST Analysis is switched to ON when using STE measurement. A software upgrade will be installed as a permanent correction.
Contact Information 1800 251 400 - Philips Customer Care Centre