October 2021 : CR 2021-PD-DXR-012 : CombiDiagnost R90/ProxiDiagnost N90 - Missing Warning Label on the Monitor.
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 : [email protected]
