Food, drugs, devices › TomoTherapy Incorporated
Device recall: TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art
TomoTherapy Incorporated (Madison, WI) initiated this device recall on 16 Jul 2014; FDA lists 1 product record under event 68960, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Jul 2015. Initiation: voluntary: firm initiated. TomoTherapy Incorporated has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TomoTherapy Incorporated, Madison, WI.
Reason for recall
"Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions."
Distribution
"Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2240-2014 | 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 therapy, stereotactic radiotherapy, or… | 168 (75 US; 93 OUS) | Class II | Terminated | 27 Aug 2014 |
Context
Other enforcement events for TomoTherapy Incorporated
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Nov 2014 | 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) | Device | Class II | 1 |
| 17 Jul 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 | Device | Class II | 1 |
All 3 events for TomoTherapy Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.