PlainRecalls
FDA Devices Moderate Class II Terminated

TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional c

Reported: January 3, 2018 Initiated: November 17, 2017 #Z-0289-2018

Product Description

TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

Reason for Recall

Uncontrolled couch Z-axis movement (descent)

Details

Recalling Firm
Accuray Incorporated
Units Affected
87 units
Distribution
Worldwide Distribution
Location
Madison, WI

Frequently Asked Questions

What product was recalled? ▼
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.. Recalled by Accuray Incorporated. Units affected: 87 units.
Why was this product recalled? ▼
Uncontrolled couch Z-axis movement (descent)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2018. Severity: Moderate. Recall number: Z-0289-2018.

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