| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00894-1 |
| Product Name/Description |
Philips Ingenia Elition S and MR 7700 Systems with SW version R5.9
Product codes: 46086 and 65009
ARTG 372370
(Philips Electronics Australia Ltd - MRI system full-body superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/10/2023 |
| Responsible Entity |
|
| Reason/Issue |
Multiple Software issues for Philips Magnetic Resonance (MR) systems with SW version R5.9 that could affect the performance of the equipment. The issues have no clinical impact. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact users to schedule time for a Field Service Engineer (FSE) to visit sites and install the software update to resolve the issues listed in Appendix A (refer to FCO78100563).
The software upgrade will also include software enhancements to improve clinical experience. Software upgrade implementation is scheduled to begin by end of Oct 2023. |
| Contact Information |
1800 251 400 - Philips Service Delivery |