Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1

 

 

Affected Medical Device : Digital Linear Accelerator

 

MDA Reference Number : MDA/FCA/2021-P135

 

MDA Registration Number : 

GC73830983018

GC227501186818

GC23765696518

GC76319499317

 

Decription : Two events have been reported where, after removal from the machine, Diode D1 has ruptured, spraying shattering pieces in the area where it was stored.

 

Local Establishment Contact Detail :

Wan Muhammad Hafis bin Wan Ishak
QA/RA Executive
ABEX Medical System Sdn Bhd
Tel: 603 - 5191 6633 Ext 626
Website: www.abexmedical.com.my

Email : muhdhafis@abexmedical.com.my

 

A copy of FSN. (please contact establishment)