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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01105-1
Product Name/Description Xper Flex Cardio Patient Monitoring System

Model Numbers: FC2010 and FC2020

All systems distributed prior to September 2015

ARTG Number: 229631
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/11/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The SpO2 and non-invasive blood pressure (NIBP) waveform and numeric values displayed on the device may freeze, resulting in the display of measurements that are not current.
Should this problem occur, SpO2 and NIBP will no longer function, including alarms. This may result in a delay in detecting important changes in a patient’s cardiovascular and respiratory condition.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users that the devices can continue to be used provided that each monitored patient is closely observed by a qualified healthcare professional. A software upgrade will be installed on all affected devices as a permanent correction.
Contact Information 1800 251 400 - Philips Customer Care Centre