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Open, Classified

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Recall Z-0443-2024 · Posted 2023-12-01

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2023-10-25
Product Quantity1019 units

Reason for Recall

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

Firm Action

Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction.

Root Cause

Under Investigation by firm

Distribution Pattern

worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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