Initial Report for CR-2021-PD-US-005 (FCO79500535) - Philips EPIQ & Affiniti Ultrasound Systems Lock Up Issue

 

Affected Medical Device : Phlips EPIQ & Affiniti Ultrasound Systems

 

MDA Reference Number : MDA/FCA/2021-P125

 

MDA Registration Number : 

GB5177020-47048
GB5211120-46712
GB5815420-46020
GB6655620-47046
GB6707820-46019

 

Decription : Due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for EPIQ & EPIQ Affiniti Ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use.

 

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.