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.
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 used for radiation therapy with identified 'potential safety issues' (anomalies). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
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). The recall is being conducted because the company has identified potential safety issues, or anomalies, associated with these specific software versions.
The affected product is the TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003. This system is intended for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues. The recall involves 168 units distributed worldwide, including 75 units in the United States and 93 units outside the United States.
The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the recall, nor does it list specific symptoms or adverse events. Users of the affected software versions should contact their medical device provider or Accuray for further guidance.
The recalled product
- 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…
- Manufacturer
- TomoTherapy Incorporated
Distribution
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