Field Safety Notice AX070/21/S : Potential software issue on Artiszee/Q/Q.zen systems with software version VD12

 

 

Affected Medical Device : VD12 Artis zee/Artis Q/Artis Q.zen

 

MDA Reference Number : MDA/FCA/2021-P149

 

MDA Registration Number : GC94505212917

 

Decription :

If SID (source to image distance) lift movement is activated and Xray shall be released simultaneously then Xray is not possible and the message "No X-ray, try again" is displayed.

 

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.