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 : zam.zarina@philips.com

 A copy of FSN.