FDA-Device2026-02-04Class IIPROCESSING DEFECT
Elekta linear accelerators recalled for electrical grounding manufacturing defect
What this means
Elekta medical linear accelerators used in cancer radiation therapy have a manufacturing defect affecting electrical grounding in certain models and lot codes. The issue could potentially affect the safe operation of these systems. No injuries have been reported to date.
- If your facility operates an Elekta Synergy, Harmony, Infinity, or Versa HD system, verify your lot code against the recall notice
- Contact Elekta immediately for instructions on inspection, repair, or replacement
- Do not operate the system if you believe it may be affected until you have confirmed with Elekta
The agency's original wording
Hazard
Due to a manufacturing issue and electrical grounding of systems.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide
Affected count
5391
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.