Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT and CT 3500 systems [Reference number: 728143, 728144, 728146, 728148, 728149, 728134, 728138] [HKMD No.: 180534].

According to the TGA, 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).

For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00747-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 Aug 2023