December 2021 : Notification on Initial Report for CR-2021-IGT-PUN-011 (FCO71800101) - Zenition 70 Wireless Footswitch Safety Notification : Wireless footswitch connection issues causing interruption of live Fluoroscopy imaging or exposure
Notification on Initial Report for CR-2021-IGT-PUN-011 (FCO71800101) - Zenition 70 Wireless Footswitch Safety Notification : Wireless footswitch connection issues causing interruption of live Fluoroscopy imaging or exposure
Affected Medical Device : Zenition 70
MDA Reference Number : MDA/FCA/2021-P175
MDA Registration Number : GC2523519-30212
Description :
Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware issue 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]
