FMI 85459 : Potential to display incomplete patient imaging study in Centricity Universal Viewer Zero Footprint configured with a Centricity PACS back end.

 

 

Affected Medical Device : Centricity Universal Viewer Zero Footprint Client

 

MDA Reference Number : MDA/FCA/2021-P154

 

MDA Registration Number : GB55729465417

 

Decription : GE Healthcare has become aware of a potential safety issue associated with the viewing of incomplete studies with Centricity Universal Viewer Zero Footprint (ZFP).

 

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.