Print version of this report
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 Philips Electronics Australia Ltd
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