| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00425-1 |
| Product Name/Description |
Expression MRI Patient Monitoring System
(Used to monitor vital signs of patients undergoing MRI procedures)
Product Code: 865214 (In vivo Expression MRI Patient Monitoring System)
Serial Numbers: US31204924, US31205148, US31205180, US42707074, US42707166, US42707375, US42707396
ARTG Number: 189095 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Recent revisions of the device’s Instructions for Use (IFU) (Part Number 989803162691, Rev. F- Rev. H) inaccurately indicates that one of the temperature probe’s application sites is “endotracheal”. The application site should be listed as“esophageal”. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal site placement..
Should the FlexTEMP reusable temperature sensor be inserted into the patient’s trachea, patient infection or airway blockage may occur if any part of the FlexTEMP temperature sensor or FlexTEMP System Jacket is left in the patient upon removal, or if the FlexTEMP System Jacket is damaged and sterilization compromised. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing the customers with an errata sheet to the Expression IFU, which removes endotracheal as an application site. Philips is working on a solution to this issue and once a solution is available, Philips will provide the customers with another communication outlining the plans for implementing the solution. This action has been closed-out on 24/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |