HIGH

Elekta Recalls Medical Linear Accelerators Due to Grounding Issues

Elekta recalled 5,391 medical linear accelerators on December 14, 2025. A manufacturing issue related to electrical grounding poses a serious hazard. Patients and healthcare providers must stop using these devices immediately.

Quick Facts at a Glance

Recall Date
December 14, 2025
Hazard Level
HIGH
Brand
Elekta
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Due to a manufacturing issue and electrical grounding of systems.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Elekta medical linear accelerators are used for delivering targeted radiation therapy to patients with cancer. They are essential for modern oncology practices, allowing for precise treatment delivery.

Why This Is Dangerous

The grounding issue may lead to electrical malfunctions, which could pose serious risks to patient safety and treatment efficacy. Proper grounding is critical for the safe operation of such medical devices.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall requires immediate action from healthcare providers and patients, potentially disrupting ongoing treatments and creating safety concerns.

Practical Guidance

How to identify if yours is affected

  1. Check the model and lot codes of your Elekta device against the recall list.
  2. Look for any notifications from Elekta regarding this recall.
  3. Contact your healthcare provider to verify if your device is affected.

Where to find product info

You can find model and lot codes on the device's labeling or user manual.

What timeline to expect

Expect a processing time of 4-6 weeks for refunds or replacements.

If the manufacturer is unresponsive

  • Document all attempts to contact Elekta and keep records of communications.
  • Consider reaching out to your healthcare provider for assistance.
  • File a complaint with the FDA if there is no response.

How to prevent similar issues

  • Look for FDA clearance and safety certifications when purchasing medical equipment.
  • Research the manufacturer's safety record before buying medical devices.
  • Stay informed on recalls and safety notices from manufacturers.

Documentation advice

Keep records of all communications with the manufacturer, including emails and letters, as well as any relevant receipts or documentation related to the device.

Product Details

The recall affects the Elekta Synergy, Elekta Harmony, Elekta Infinity, and Versa HD models. These devices have lot codes including 05060191071550, 05060191071505, 05060191071543, and others. The products were distributed worldwide.

Key Facts

  • Recall date: December 14, 2025
  • 5,391 units recalled
  • Electrical grounding issue identified
  • Patients and providers advised to stop use immediately
  • Worldwide distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
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
Report Date
February 4, 2026
Recall Status
ACTIVE

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