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TGA Action ID	RC-2025-RN-00477-1
Type of Product	Medical Device
Product Name/Description	IntelliSpace Cardiovascular 6.x, 7.x, and 8.x Reference Number: 830089
ARTG Number	383514
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Philips has identified a software problem affecting IntelliSpace Cardiovascular (ISCV) software versions 6.x, 7.x, and 8.x. The problem occurs within the Echo Module of ISCV and may lead to missing or incomplete information when Finding Codes are used, under the following circumstances: a) When the same Finding Code is added into multiple Finding Groups in the same section, all of the expected Finding Codes do not appear in the report, or b) If the Finding Code is sent to the conclusion section of the report by double clicking the Finding Code, the expected Finding Code does not appear in the conclusion of the report. The problem was discovered during internal testing. There have been no customer complaints or reported adverse events, and use of or exposure to the product is not likely to result in any adverse health consequences. Update 22/01/2026 - Phillips has clarified that this problem occurs in both the Echo Module and Vascular Ultrasound Module. The affected software now includes version 6.1, 6.2, 7.0, 7.1, and 8.0
Instructions for Customers/Users	· Customers are advised to verify that any text added into the report conclusion matches the data in the work area interpret sheet. · Customers may continue to use their systems in accordance with the intended use, provided they follow the verification recommendation. · Customers are to review the workflows described in Attachment A provided in the customer letter and identify whether either of this workflow is currently in use or planned to be used at their facility. · Customers who do not currently use the affected workflows but plan to in the future are advised to contact Philips Informatics Customer Support to ensure that the correction is implemented before initiating use of the workflows. · Customers are advised that a Philips representative will contact those using or intending to use the affected workflows to schedule installation of the software solution. · Customers are to note that three Field Change Orders (FCO’s) will be developed to address this problem. These are planned for release in Q2 of 2026 and will apply to systems utilizing the affected workflows. Update 22/01/2026 - Customers should refer to Section 4 of the Customer Letter to see the updated guidance for continued use prior to software solution implementation. Philips also plans to implement the software solution on all systems.
Action Commencement Date	21/05/2025
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team