The Recall Desk

FDA (Devices) recall action 78686

Accuray Incorporated recalled 4 products on 2018-01-03

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-01-03
Critical
0
Units
484

Why these products were recalled

Uncontrolled couch Z-axis movement (descent)

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • HighFDA (Devices)··2018-01-03

    Accuray TomoHD System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.

    Product
    TomoHD(R) System, Model Number 1018283 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…
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    0 states
  • SevereFDA (Devices)··2018-01-03

    Accuray TomoHDA System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.

    Product
    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…
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    0 states
  • SevereFDA (Devices)··2018-01-03

    Accuray TomoH System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.

    Product
    TomoH(R) System, Model Number 1018284 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…
    Category
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    0 states
  • SevereFDA (Devices)··2018-01-03

    Accuray Hi-Art System Recalled for Uncontrolled Couch Movement

    Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.

    Product
    Hi-Art(R) System, Model Number H-000-0003 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…
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    0 states