Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning GE Hangwei Medical Systems Co., Ltd. Revolution Ascend and Revolution Maxima Systems [HKMD No.: 241075].
According to the TGA, the manufacturer has become aware of a potential problem on certain Revolution series CT systems that can result in rotated CT images. Particularly with helical, cine, and cardiac scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of 56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-01035-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Nov 2024