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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00747-1
Product Name/Description	Philips Incisive CT and CT 3500 systems Reference number: 728143, 728144, 728146, 728148, 728149, 728134, 728138 ARTG 229637 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) ARTG 352131 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/08/2023
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	There are three software issues affecting software version 5.0., with the potential for unintended radiation. Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time (Impacts only Incisive CT systems). Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area (Impacts Incisive CT systems and CT 3500 systems). Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm (Impacts only Incisive CT systems). Philips has identified additional issues with software version 5.0 affecting Incisive CT systems, further information is provided in the customer letter (supplied by Philips to affected customers). Philips has not received any reports of adverse events associated with these issues.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers may continue to use your system(s) in accordance with the intended use and the following actions are recommended to mitigate the identified issues: · Issue 1: Start the clinical scan manually by clicking the Start Clinical Scan when the tracker image shows the contrast intake is reasonable. The issue will not occur when the rotation time setting is greater than 0.4s. · Issue 2: Do not use any aborted surview for scan planning in a new exam. · Issue 3: Do not perform the whole-body scan with surview over the length of 1832mm. · Please retain this letter with your system(s) until a software solution is installed; ensure the notice is in a place likely to be seen/viewed. ·Refer to customer letter for specific details Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install a software update to resolve these software issues.
Contact Information	1800 251 400 - Philips Service Delivery Team