Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0443-2024 — ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

U.S. FDA — Device Enforcement · United States · 2023-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0443-2024
Date of alert
2023-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05060191071505
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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