Initial Report for CR-2021-IGT-BST-011 (FCO72200484) - Leakage of cooling fluid of flat detector in the R-cabinet ®

 

 

Affected Medical Device : Philips Allura Xper

 

MDA Reference Number : MDA/FCA/2021-P173

 

MDA Registration Number : GC97115121117

 

Description :

Philips has discovered a problem with the flat detector cooling system. Due to a leak in the flat detector cooling system, cooling liquid may leak outside the drip tray of the Laird chiller. If this occurs, the liquid may drip into electrical components in the R-cabinet located in the technical room which could cause damage to the system.

 

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.