ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD

There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.

On December 6, 2017 Elekta sent notification to their customers informing them the following: Description of Problem: Elekta has identified that if the microswitch within the middle arm is not set up correctly, it is possible for the MV or kV detector arm to extend due to gravity. When the detector arm is fully open there is no risk. Details: In order for an uncontrolled extension to occur on a detector arm, the following conditions must be present: The microswitch (within the Solenoid Limit Switch of the PCB assembly in the middle arm) is activated incorrectly. The detector-locked solenoid is not fully engaged in the interface bracket. This is most likely to lead to a potential collision in the following scenarios: iViewGT - The detector arm is opened or closed above the patient, when the gantry angle is at 180 ( 45). XVI - The detector arm is opened or closed above the patient, when the gantry angle is at 90 ( 45) Clinical Impact: It is possible that a collision with the extended detector arm can cause serious injury. Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions For Use (IFU). Elekta Corrective Actions: Elekta Field Service Representatives will do checks to make sure that that the microswitch activates only when the detector-locked solenoid is fully engaged in the interface bracket. If you have any concerns, contact your Elekta Field Service Representatives who are aware of how to do these checks. This notice has been provided to the appropriate Regulatory Authorities. We sincerely apologize for any inconvenience this action may cause and thank you in advance for your cooperation.