Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

On September 5, 2017 Forte has distributed an Urgent Medical Device Correction letter with the following information, Subject: Robotic Treatment Table Positioning Error Commercial Name of Affected Product: Patient Positioning System Affected Version(s) / Lot(s): KRC2 Controllers with software version 2.3.1 2.3.10 Reference / FSCA Identifier: 3003900998-2017-00001 Type of Action: Notification and Correction This letter provides users with a Description of the Problem, Details, Recommended User Action and Forte Automation Systems, Inc. Actions. This document also Pending resolution with a permanent solution, Forte Automation Systems, Inc. recommends reimaging the patient prior to treatment, especially after any table movement. This includes movement initiated by the image position verification system. It also advises users that a solution for the issue is in development.