FDAClass IIFebruary 4, 2026

Brand Name: Elekta Medical Linear Accelerator Product recall

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product…

Why was Brand Name: Elekta Medical Linear Accelerator Product recalled?

Due to a manufacturing issue and electrical grounding of systems.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product…
Recalling firm
Elekta, Inc.
Quantity
5391
Distribution
Worldwide
Recall date
February 4, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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