Field Corrective Action Notification CA310-0018 : DRYPRO SIGMA - Procedure for replacing defective cable between MCS and ET motor

 

Affected Medical Device : DRYPRO SIGMA

 

MDA Reference Number : MDA/FCA/2021-P103

 

MDA Registration Number : GMD42528502718A

 

Decription : Defect was found in the cable between MCS and ET in 165 units of DRYPRO SIGMA which produced in this March and April.

 

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.