Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Healthcare Incisive CT [Software 5.0.0.531; Models 728143 and 728144] [HKMD No.: 180534].

According to TGA, the manufacturer has identified three software issues in the Philips Incisive CT system that, if they were to reoccur, could affect the performance of the equipment.

1. Oblique MPR image issue during a head scan with feet first, images are displayed upside-down or reversed. If this occurs during the oblique planning Multi-Plane Reconstruction (MPR) after a head scan with feet first, there is a potential for the oblique MPR images to be displayed upside-down or reversed (e.g., the image may be flipped either 180 degrees or mirrored). If the image is displayed incorrectly, then this may lead to a misdiagnosis.
2. Labelling issue with Lumbar batch.
3. Not able to shorten the scan length to less than 250mm when the Exam Card contains precise image reconstruction.

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00665-1

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

Posted on 5 May 2022