October 2021 : FMI 85459 : Potential to display incomplete patient imaging study in Centricity Universal Viewer Zero Footprint configured with a Centricity PACS back end.
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 : [email protected]
