Home / Recalls / Elekta, Inc. / Z-1164-2026

Z-1164-2026 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
February 4, 2026
Initiation Date
December 14, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5391

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

Reason for Recall

Due to a manufacturing issue and electrical grounding of systems.

Distribution Pattern

Worldwide

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

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