| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00829-1 |
| Product Name/Description |
Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)
Product Code: 865471
Serial Numbers: US23200375, US23200376, US23200377
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
When contact electrostatic discharge (ESD) is applied to one of the four screws on the rear enclosure panel of the IP5, the wireless function of the IP5 radio could be interrupted. If this were to occur, there could be a loss of wireless communication between the IP5 and host monitoring system, the Expression MRI Patient Monitoring System or the Expression MR200 MRI Patient Monitoring System. This could potentially lead to a delay in treatment or diagnosis of the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips representative will contact affected customers to arrange for the addition of two ferrite clamps to a cable located inside the device to protect against an electrical pulse from ESD.
Philips has advised that the IP5 can continue to be used and have provided work around instructions to reduce the risk of electrical pulse from ESD. This action has been closed-out on 1/06/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |