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