Elekta, Inc.: Device Recall

Recall #Z-1164-2026 · 12/14/2025

Class II: Risk

Recall Details

Recall Number: Z-1164-2026
Classification: Class II
Product Type: Device
Recalling Firm: Elekta, Inc.
Status: Ongoing
Date Initiated: 12/14/2025
Location: Atlanta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5391

Reason for Recall

Due to a manufacturing issue and electrical grounding of systems.

Product Description

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

Distribution Pattern

Worldwide

Other Recalls by Elekta, Inc.

Class II: Risk 12/10/2025

Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Class II: Risk 09/30/2025

Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Class II: Risk 01/15/2025

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

View all recalls by Elekta, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.