medical MODERATE Updated 2026-02-04

Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name:

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Recalled 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

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Hazard / Issue

Due to a manufacturing issue and electrical grounding of systems.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: 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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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