| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01029-1 |
| 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, US23200377
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/09/2014 |
| 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. This could result in delay in treatment of the patient caused by the displayed numeric value not correlating with the patient's status.
This is an update to the previous recall for product correction (TGA Ref.: RC-2014-RN-00349-1) which informed end users to ensure that the IP5 should be power cycled every 24 hours to prevent the above issue from occurring. Now a permanent software solution is available. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips representative will contact the customers and all affected devices will have a software update installed in order to address the problem. After the software update is installed, if the device is allowed to run for an extended period of time, the device will begin to notify users of the need to power cycle the device using various degrees of warning “restart required” prompts (dialog boxes). If the device is not power cycled when this time expires, the device will power down and sound a tone to inform users of the action. Until the software solution is implemented, users should ensure that the IP5 is power cycled once every day. This action has been closed-out on 5/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |