Julai 2021 : Corrective action reporting for FMI 60978 : Incorrect Image Annotation and/or Flipped Images as a result of Inadvertently Changing the PrescribedPatient Orientation. SIGNA Premier, Signa Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discov
Corrective action reporting for FMI 60978 : Incorrect Image Annotation and/or Flipped Images as a result of Inadvertently Changing the PrescribedPatient Orientation. SIGNA Premier, Signa Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, SIGNA Voyager, Optima MR450w 1.5T, SIGNA Artist, SIGNA Creator, SIGNA Explorer, SIGNA MR355, SIGNA MR360, SIGNA MR380, Discovery MR450 1.5T, 1.5T Signa HDxt (HD28)
Affected Medical Device :
DISCOVERY MR750W 3.0T
OPTIMA MR450W 1.5T
SIGNA VOYAGER
SIGNA CREATOR / SIGNA EXPLORER
SIGNA PET/MR
SIGNA ARTIST
SIGNA Architect
SIGNA Premier
SIGNA PIONEER
SIGNA CREATOR / SIGNA EXPLORER HYBRID
MDA Reference Number : MDA/FCA/2021-P099
MDA Registration Number :
GB53159380417
GB17854320917
GB92104485417
GB35915559018
GB63311558718
GB82459707118
GB64661812518
GB4732721-52963
GB93427812918
GB99404728218
Decription : Issue on the affected products listed below where the “Patient Orientation” button can inadvertently be clicked when intending to click on the “Save RX” button.
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]
