October 2021 : FMI 25500 : Potential SmartStep Dose display error on Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex Edition Systems
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 : [email protected]
