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 : nur-ayuni.abas@siemens-healthineers.com

 

 A copy of FSN.