Field Corrective Action Notification 200-06-103-090 : Digital Accelerator - CITB external interlock check

 

Affected Medical Device : 

Elekta Synergy

Precise Digital Accelerator

Elekta Infinity

Versa HD

 

MDA Reference Number : MDA/FCA/2021-P106

 

MDA Registration Number : 

GC73830983018
GC227501186818
GC23765696518
GC76319499317

 

Decription : Check the connections to the CITB for the customer required external interlocks and confirm with the customer that they are correct. Update the calibration values to enable the External Terminate and Room Doors 3 inputs (software interlocks) which have been disabled by default in the calibration.

 

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 : [email protected]

 

 A copy of FSN.