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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01486-1
Product Name/Description Brainlab Navigation System Spine & Trauma 3D

Serial Numbers: XXXXXXXX-19154-03 and XXXXXXXX-19154-04

ARTG Number 96517
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/12/2017
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue Brainlab has determined that due to a human error at a Brainlab supplier, an unknown number of items within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.

Due to this manufacturing error the required reproducible rigid fixation between DrapeLink C-arm Array and Adapter cannot be ensured in all cases.
Recall Action Recall
Recall Action Instructions Brainlab is advising users to isolate units with the specified serial numbers from use. A Brainlab Customer Support Representative will contact customers to arrange a service visit to collect and replace the potentially affected item.

This action has been closed out on 17/10/2018
Contact Information 02 9424 3800 - Brainlab Australia