Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug

 

 

Affected Medical Device : Multi Modality Imaging System

 

MDA Reference Number : MDA/FCA/2021-P177

 

MDA Registration Number : GC449931039218, GC338781143418

 

Description :

An error has been discovered recently in the AnyScan ver. 3.05.xxx Nucline software. The error affects the reconstruction of single field of view, static PET scans, on machines equipped with multiple GPUs. In this special case the GPUs are working on a single volume in parallel, and due to the now discovered bug, the scatter correction is incorrect.

 

Local Establishment Contact Detail :

Wan Muhammad Hafis bin Wan Ishak
QA/RA Executive
ABEX Medical System Sdn Bhd
Tel: 603 - 5191 6633 Ext 626
Website: www.abexmedical.com.my

 

Email : muhdhafis@abexmedical.com.my