Field Corrective Action Notification 80601BTP002 : Mirroring of Applicator Model may occur in Oncentra® Brachy

 

 

Affected Medical Device : FLEXITRON

 

MDA Reference Number : MDA/FCA/2021-P148

 

MDA Registration Number : GC3716519-29208

 

Decription : Oncentra® Brachy offers Applicator Modelling functionality, which aids the end-user in the reconstruction of an entire applicator geometry by using Anchor Points. In two rare scenarios, the applicator model may get mirrored. This is caused by a design fault in the mapping of the applicator model to the user provided anchor points. If unnoticed, this could result in a difference between the planned and delivered dose.

 

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]