Initial Report for CR-2021-PD-DXR-001 (FCO 70900050) - CombiDiagnost R90 - Software Package 1.1.1&1.1.2

 

Affected Medical Device : CombiDiagnost R90

 

MDA Reference Number : MDA/FCA/2021-P123

 

MDA Registration Number : GC25585319317

 

Decription : After the user selects the Lock-in command, the kV and mA values are not locked immediately and can change if the collimator shutter position is changed directly after the Lock-in command. This will lead to a change of technique factors. If the user stops and restarts fluoroscopy then the Lock-in works as specified and collimation can be changed to the needs of the examination.

 

Local Establishment Contact Detail :

Zam Zarina Mat Ail
Quality & Regulatory Manager
Philips Health Systems Malaysia
Philips Malaysia Sdn. Bhd. Level 9, Menara Axis, No.2, Jalan 51A/223, 46100 Petaling Jaya, Selangor Darul Ehsan. MALAYSIA.

Email : zam.zarina@philips.com

 

 A copy of FSN.