Elekta recalled 5,391 medical linear accelerators on December 14, 2025. A manufacturing issue related to electrical grounding poses a serious hazard. Patients and healthcare providers must stop using these devices immediately.
Due to a manufacturing issue and electrical grounding of systems.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Elekta Synergy, Elekta Harmony, Elekta Infinity, and Versa HD models. These devices have lot codes including 05060191071550, 05060191071505, 05060191071543, and others. The products were distributed worldwide.
The manufacturing issue may lead to inadequate electrical grounding. This condition increases the risk of malfunction, which can compromise patient safety.
No specific incidents or injuries have been reported related to this recall. However, the potential for serious harm exists due to the high hazard level.
Stop using the affected devices immediately. Contact Elekta, Inc. or your healthcare provider for further instructions and follow the recall guidelines provided.
For more information, contact Elekta, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1164-2026.
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