| 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 |
|
| 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 |