Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00644-1 |
Product Name/Description |
Philips MR systems
Software version: R11.1
Multiple product models and product codes
ARTG's: 230064 & 372370 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
7/08/2024 |
Responsible Entity |
|
Reason/Issue |
Philips has identified software problems with the Philips MR systems with SW version R11.1 that could affect the performance of the equipment.
To address and rectify the problems, Philips has released Service Pack 3.
The defects may impact clinical workflow, therefore performance.
As of 29-MAY-2024, Philips has not received any reports of adverse events associated with these problems. |
Recall Action |
Product Defect Correction |
Recall Action Instructions |
Customers are to:
- Confirm that the system is one of the models listed in Appendix A, and that it has software version R11.1.
To identify the software version: Navigate to the main screen of the operator(s) console and select the question mark symbol or press F1 key.
- Continue to use your system(s) in accordance with the IFU.
- Refer to Appendix B for specific details regarding the SW issue descriptions and advice to customers.
Philips will contact customers to schedule a time for a Field Service Engineer (FSE) to install the software upgrade (reference FCO78100589). The software upgrade will also include the latest security update. |
Contact Information |
1800 251 400 - Philips Service Delivery Team |