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.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 322
Distribution
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