The Recall Desk

FDA (Devices) recall action 86993

Accuray Incorporated recalled 2 products on 2021-01-13

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-01-13
Critical
0
Units
15

Why these products were recalled

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

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2021-01-13

    Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

    Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    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 r
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2021-01-13

    Accuray TomoTherapy System Recalled for MLC Tickling Error

    Accuray is recalling seven TomoTherapy Treatment Systems because an MLC tickling error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment System - 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 h
    Category
    Distribution
    8 states