FDA recall, , Moderate risk
Elekta Synergy, Harmony, Infinity and Versa HD Linear Accelerators
The digital linear accelerators have a manufacturing issue with electrical grounding.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc., of Atlanta, Georgia, recalled its Elekta Synergy, Elekta Harmony, Elekta Infinity, and Versa HD digital linear accelerators due to a manufacturing issue and electrical grounding of systems. The recall began on December 14, 2025, and was added to the FDA's Enforcement Report on January 23, 2026. The products were distributed worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Elekta Medical Linear Accelerator Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
- UDI-DI
- 05060191071550
- 05060191071505
- 05060191071543
- 05060191071512
- 05060191071574
- 05060191071529
- 05060191071581
- 05060191071604
- 07340201503461
Recall details
- Company began the recall
- Sold in
Worldwide
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97958
- Recall number
- Z-1164-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
