Corrective action reporting for FMI 15145 : Potential early Coin Cell Battery depletion on OEC Elite systems manufactured on or after January 2019 and all OEC 3D mobile C-Arm systems.

 

Affected Medical Device : OEC Elite

 

MDA Reference Number : MDA/FCA/2021-P105

 

MDA Registration Number : GC35179812618

 

Decription : Potential issue related to certain OEC Eliteand OEC 3D mobile C-Arms. Service recorddata has shown anincreasedreplacement rate than previously observed of thecoin cell battery used to monitor X-Ray tube temperature.

 

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.