Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Healthcare (Suzhou) Co., Ltd Incisive CT system [Software version: 5.0; Reference numbers: 728143, 728144, 728149, 728146, 728148 & 728151] [HKMD No.:180534].

According to the TGA, the manufacturer has identified multiple software issues affecting Incisive CT systems which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels or the need for a CT rescan. Issues identified that may occur include:

1. Artifacts in the images on perfusion images.
2. Orientation label reversed in 2D images.
3. Auto voice issues.
4. Not all images are reconstructed, or no image is displayed on the console monitor after enabling CCT single scan.
5. Ring artifact appears when soft tissue view is selected.
6. Error 0503 (HG000A00503) occurs during scanning process.
7. Calcium scoring study split into separate series after loading to ISP.

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00084-1

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

Posted on 17 Feb 2023