Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Elekta Medical Linear Accelerators Recalled for Electrical Grounding Issue

Agency Publication Date: January 23, 2026
Share:
Sign in to monitor this recall

Summary

Elekta, Inc. is recalling 5,391 medical linear accelerators, including the Synergy, Harmony, Infinity, Versa HD, Harmony Pro, and Evo models. These digital devices, used for radiation therapy, are being recalled due to a manufacturing issue involving improper electrical grounding of the systems. Elekta is notifying affected facilities by letter to arrange for necessary system corrections.

Risk

Faulty electrical grounding in these systems poses a risk of electrical shock to both patients and healthcare providers. It may also lead to unexpected system malfunctions or shutdowns, which could delay or disrupt critical radiation treatments.

What You Should Do

  1. This recall affects Elekta Medical Linear Accelerators, which are digital devices used for radiation therapy. Affected models include the Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Harmony Pro, and Elekta Evo.
  2. Identify affected systems by checking for the following lot codes: 05060191071550 (NFB), 05060191071505 (FB), 05060191071543 (NFB), 05060191071512 (FB), 05060191071574 (NFB), 05060191071529 (FB), 05060191071581, 05060191071604, or 07340201503461.
  3. Stop using the recalled device immediately. Contact Elekta, Inc. or your equipment distributor to arrange for a system inspection and necessary grounding corrections.
  4. For additional information, contact the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

System correction and electrical grounding inspection.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Elekta Synergy Digital Linear Accelerator
Variants: NFB, FB
Model / REF:
Synergy
Lot Numbers:
05060191071550 (NFB)
05060191071505 (FB)
Product: Elekta Infinity Digital Linear Accelerator
Variants: NFB, FB
Model / REF:
Infinity
Lot Numbers:
05060191071543 (NFB)
05060191071512 (FB)
Product: Versa HD Digital Linear Accelerator
Variants: NFB, FB
Model / REF:
Versa HD
Lot Numbers:
05060191071574 (NFB)
05060191071529 (FB)
Product: Elekta Harmony Digital Linear Accelerator
Model / REF:
Harmony
Lot Numbers:
05060191071581
Product: Elekta Harmony Pro Digital Linear Accelerator
Model / REF:
Harmony Pro
Lot Numbers:
05060191071604
Product: Elekta Evo Digital Linear Accelerator
Model / REF:
Elekta Evo
Lot Numbers:
07340201503461

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97958
Status: Active
Manufacturer: Elekta, Inc.
Manufactured In: United States
Units Affected: 5391
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.