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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00404-1
Product Name/Description	ROSA Brain 3.0.0 Robotic Surgical Assistant Serial Number: BR15002 ARTG Number: 235379
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/03/2017
Responsible Entity	Surgicom Pty Ltd
Reason/Issue	Investigation revealed that a computer file parameter that is linked to the robot arm calibration has been modified by the robot arm supplier without notification to the manufacturer. As a result, once the robot arm is on a trajectory, if the system reboots or shuts down (voluntarily or due to an error) without the robot arm returning to a Parking position, the device’s applicative accuracy may decrease to a level below the applicable specification. In the event that the inaccurate tool positioning of the instruments by the ROSA devices is not detected by the user, it could ultimately lead to ineffective treatment, serious injury or death of the patient. To date, no complaint reports, which could be linked to the above issue in normal conditions of use, have been recorded.
Recall Action	Recall for Product Correction
Recall Action Instructions	As an interim measure, Surgicom is requesting users to follow the instructions as detailed in the recall notification letter. This action has been closed-out on 15/03/2018.
Contact Information	02 9809 7234 - Surgicom