| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00349-1 |
| Product Name/Description |
Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)
Product Code: 865471
Service Number: 453564251511
Serial Numbers: US23200375, US23200376 and US23200377
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Continuous use of the IP5 for more than 24 days, without power cycling, results in a graphical user interface (display screen) error, which causes the numeric data on the display to freeze and disables some menu keys. Waveform data displayed and audible alarms are not impacted by this problem and continue to function properly. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising end users to ensure that the IP5 is power cycled every 24 hours. A correction is being investigated and will be provided once available. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |