2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System

 

 

Affected Medical Device : Intuis System

 

MDA Reference Number : MDA/FCA/2021-P137

 

MDA Registration Number : GC25539161917

 

Decription : software defect that randomly causes a situation where the X-ray is not activated when pressing the footswitch.

 

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.