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

Recall Z-0785-2021 — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital he

U.S. FDA — Device Enforcement · United States · 2020-12-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0785-2021
Date of alert: 2020-12-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accuray Incorporated
Product category: device
Product type: Devices

Reported risk: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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