CR 2021-PD-DXR-012 : CombiDiagnost R90/ProxiDiagnost N90 - Missing Warning Label on the Monitor.

 

 

Affected Medical Device : CombiDiagnost R90/ProxiDiagnost N90

 

MDA Reference Number : MDA/FCA/2021-P147

 

MDA Registration Number : GC625521251919

 

Decription : X-ray warning label(s) are missing from the Eleva Examination Console on CombiDiagnost C90 and ProxiDiagnost N90 systems. Regulations require that these labels be affixed to the system.

 

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.