November 2021 : Field Safety Notice CT067/21/S : Possible degradation of image quality in head scans when using the CT system.
Field Safety Notice CT067/21/S : Possible degradation of image quality in head scans when using the CT system.
Affected Medical Device :
SOMATOM Confidence
SOMATOM Definition Edge
SOMATOM Definition Edge Plus
SOMATOM Definition AS
with syngo.CT VB20A_SP5
MDA Reference Number :
MDA/FCA/2021-P163
MDA Registration Number :
GC29972314417
GC18552244817
Decription :
possible degradation of image quality in head scans when using your CT scanner with software syngo.CT VB20A_SP5.
Local Establishment Contact Detail :
Nur Ayuni Abas
Siemens Healthcare Sdn. Bhd.
SHS AP ASN MAS QT
Level 16, CP Tower,No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya, Selangor, Malaysia
Tel.: +60 3 7952-5236
Email : [email protected]
