Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD So

FDA device recall Z-1164-2026 · posted 2026-01-23 · Open, Classified

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Due to a manufacturing issue and electrical grounding of systems.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

IYE

Quantity affected

5391

Distribution

Worldwide

Date initiated

2025-12-14

Date posted

2026-01-23

Location

Atlanta, GA

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