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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Elekta linear accelerators recalled for electrical grounding manufacturing defect

Elekta
ELECTRICAL SHOCKNationwide distribution

Check your Elekta radiation therapy system

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
Hazard

Due to a manufacturing issue and electrical grounding of systems.

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-1164-2026

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