October 2021 : Initial Report for CR 2021-IGT-BST-020 Allura Xper and Azurion systems - Wireless footswitch lost connection
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 : [email protected]
