FMI 25500 : Potential SmartStep Dose display error on Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex Edition Systems

 

 

Affected Medical Device : 

Revolution CT
Revolution CT ES
Revolution Apex
Revolution CT with Apex edition

 

MDA Reference Number : MDA/FCA/2021-P151

 

MDA Registration Number : 

GC57940813018
GC5918120-42407

 

Decription :

An issue where the accumulated dose is incorrectly displayed in certain situations. This occurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. The system will accuratelydeliver the prescribed dose even if the table is moved following examinitiation.

 

Local Establishment Contact Detail :

Benedict Lee
ASEAN Regulatory Affairs Specialist
GE Healthcare Sdn Bhd
Level 6, 1 Sentral, Jln Travers, KL Sentral, 50470 KL
03 22739788

Email : benedict.lee@ge.com

 A copy of FSN.