Elekta linear accelerators recalled for electrical grounding manufacturing defect
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.
From the FDA notice · Read the official notice ↗ · All Elekta recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (under 100 years)
Details
- Units affected
- 5391
- Illnesses reported
- None reported
- Manufactured in
- 400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
- Classification
- Class II
- Recall number
- Z-1164-2026
In the FDA's words
- Description
- 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 Due to a manufacturing issue and electrical grounding of systems. 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 Distribution: Worldwide Affected quantity: 5391
- Hazard
- Due to a manufacturing issue and electrical grounding of systems.