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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Elekta
- Product type
- Digital Linear Accelerator
- 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
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 14, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model and lot codes of your Elekta device against the recall list.
- Look for any notifications from Elekta regarding this recall.
- 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.
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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
- Electrical grounding issue identified
- Patients and providers advised to stop use immediately
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Safety Guide
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