The Recall Desk
HighFDA (Devices)·Z-2239-2014·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with identified potential safety issues (anomalies) but no reported injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 (Hi-Art 4.2.0, 4.2.1, and 4.2.2). The recall involves the TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003.

The recall is being conducted because Accuray has identified potential safety issues, or anomalies, with these specific software versions. The source text does not specify the exact nature of these anomalies or report any injuries or illnesses.

The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international countries. A total of 322 units are involved in this recall. Users of these systems should contact Accuray or their healthcare provider for instructions on how to address the software anomalies.

The recalled product

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). .
Manufacturer
TomoTherapy Incorporated
Category
Medical Device — Radiation Therapy System
Hazard
Affected units
322

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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