Field Corrective Action CT018/21/S : SOMATOM GO.TOP - Remotely software update due to scanning workflow interruptions and unexpected user notifications

 

Affected Medical Device : SOMATOM GO.TOP

 

MDA Reference Number : MDA/FCA/2021-P126

 

MDA Registration Number : GC110591186618

 

Decription : Some technical issues have been identified in certain software versions mentioned above, and these issues may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Sporadic software errors may also occur during interventional workflows.

 

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
Fax: +60 3 7955-7331

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

 

 A copy of FSN.