The Recall Desk

Manufacturer

TomoTherapy Incorporated

3 recalls in our database name TomoTherapy Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2014-12-17

Of the 3 recalls from TomoTherapy Incorporated we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • SevereFDA (Devices)·Z-0507-2015·2014-12-17

    TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure

    TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.

    Product
    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)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    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 thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide