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

Recall Z-0507-2015 — TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)

U.S. FDA — Device Enforcement · United States · 2014-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0507-2015
Date of alert
2014-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
TomoTherapy Incorporated
Product category
device
Product type
Devices
Reported risk: Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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