| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00798-1 |
| Product Name/Description |
MR Patient Support Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition X
REF Numbers: 782107, 782108, 782109
Serial Numbers: 48627, 47657, 48696, 62147
ARTG 372370
(Philips Electronics Australia Ltd - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified a problem in the MR System Patient Support where the Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface. This could cause the screws to interfere with other moving parts, potentially blocking the horizontal table-top movement.
There have been no reports of adverse events as of March 2024. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers can continue using identified systems in accordance with the intended use.
As a reminder, when using MR systems, customers should follow the warnings listed in the IFU provided with their system under the section titled 'Moving the patient into the magnet bore'
If customers experience resistance from the table-top movement during patient scan, they should Stop-use immediately and contact their local Philips service representative.
Philips will contact customers to schedule time for a Field Service Engineer (FSE) to visit their site to inspect the IRF carrier assembly and provide a correction if necessary. Philips plans to start implementing corrections in Q4 2024. |
| Contact Information |
1800 251 400 - Philips. |