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

Recall Z-2240-2014 — TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic rad

U.S. FDA — Device Enforcement · United States · 2014-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2240-2014
Date of alert: 2014-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TomoTherapy Incorporated
Product category: device
Product type: Devices

Reported risk: Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.

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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