Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy

Due to a manufacturing issue and electrical grounding of systems.

On 12/14/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" Letter to customer informing them that Elekta has identified a safety issue relating to the modulator discharge rod, where the supplier has been fitting the crimp in the crimp tool back to front. The issue was discovered during production. Note - The discharge rod is used by Field Service Engineers (FSE) when completing service activities on the machine around the HT and RF (High Tension (high voltage) and Radio Frequency) assembly. Instructions to customer: No actions are required to be taken by the Clinical user. Instructions for Field Service Engineers: Possible impact on the Field Service Engineer:- The FSE uses the HT discharge rod to fully discharge the voltage capacitor. Once the FSE has completed the procedure using the discharge rod, the FSE will start to work on the system around the HT and RF assembly. If the discharge rod is not fully connected to the ground or not connected at all, the system will still be fully charged and the FSE could receive an electric shock. Elekta will release an Important Field Safety Modification (IFSM) to identify potentially faulty discharge rod crimping and provide further instructions. The IFSM will include procedures for verifying the reliability of the discharge rod crimping and replacing affected components if necessary. local Elekta service representative will contact you to arrange for this activity to be completed.

• FDA enforcement recordOfficial FDA database entry for Z-1164-2026
• FDA 510(k) clearance · K210500The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Elekta, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.