Initial Report for CR 2021-IGT-BST-020 Allura Xper and Azurion systems - Wireless footswitch lost connection

 

 

Affected Medical Device : Allura Xper and Azurion systems

 

MDA Reference Number : MDA/FCA/2021-P150

 

MDA Registration Number : GC59959884718

 

Decription : 

Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions coexist, such as EMC disturbance and the presence of other wireless devices in the room.

 

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.