—#217320

Product

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K210500
Affected lot / code info: Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo

Why it was recalled

Due to a manufacturing issue and electrical grounding of systems.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2025-12-14
Posted by FDA: 2026-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217320. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.