Notification on Initial Report for FCO79500549 - EPIQ Swivel Lock Failure

 

Affected Medical Device : 

EPIQ 5G
EPIQ 5C
EPIQ 5W
EPIQ 7G
EPIQ 7C
EPIQ 7W
EPIQ CVx
EPIQ Cvxi

 

MDA Reference Number : MDA/FCA/2021-P111

 

MDA Registration Number : 

GB24040480117
GB6607520-46018
GB6707820-46019
GB6735520-47047

 

Decription : The EPIQ Ultrasound Systems control panel arm locking mechanism, intended to prevent side-to -side movements, could fail, preventing it from locking properly.

 

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.