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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00927-1
Product Name/Description	Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) Serial Numbers: 124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125967-125153, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,126318-330, 126338-126373, 126375-397, 126400-133999 & 213000+ ARTG Number: 165045
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	22/08/2014
Responsible Entity	Elekta Pty Ltd
Reason/Issue	Elekta have identified that it is possible to get a positional error with the Precise Treatment Table. This can occur if the positional sensors are not correctly installed during corrective maintenance. The system has a software check for large positional errors which is intended to find faults, but it is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed. It is possible to cause a clinical mistreatment if the patient is not in the correct position.
Recall Action	Recall for Product Correction
Recall Action Instructions	Elekta recommends the customers to verify the accuracy of the treatment table position using the procedure as shown by the treatment room monitor (TRM) as part of the daily machine checks. Elekta will supply an improved method of check/test for service engineers to implement post maintenance on the potentiometers to ensure they have correctly installed the positional sensors. This action has been closed-out on 12/08/2016.
Contact Information	02 8907 1800 - Elekta Regulatory Affairs