| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00597-1 |
| Product Name/Description |
Invivo Expression MRI Patient Monitoring System - Product 865214
Units Affected - Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 - US42708744).
Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this medical device correction.
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The device's labelling inaccurately indicates “endotracheal” as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal site placement. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising end users that the FlexTEMP reusable temperature sensor cannot be in endotracheal site. Philips is working to correct this labelling issue and will contact customers with an update on its implementation plan. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |