Elekta, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1164-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: December 14, 2025

Date Posted: February 4, 2026

Recall Number: Z-1164-2026

Event ID: 97958

Reason for Recall:

Due to a manufacturing issue and electrical grounding of systems.

Status: Ongoing

Product Quantity: 5391

Code Information:

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 Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated