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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II for a medical device used in radiation therapy. While no specific injuries are reported in the text, the potential for incorrect jaw position during treatment without system interruption poses a significant risk of serious adverse health consequences, aligning with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems, including 72 units in the United States and 138 units outside the US. The affected systems are equipped with software versions 2.0.1, 2.0.2, or 2.0.3 (Hi:Art 5.0.1, 5.0.2, or 5.0.3). The recall covers units distributed worldwide, including in the US, Japan, Belgium, the Netherlands, Italy, Germany, Korea, France, Switzerland, England, Canada, Mexico, Hong Kong, Australia, Sri Lanka, Greece, China, the Philippines, Martinique, Romania, Spain, and Turkey.
The recall is due to a potential safety issue where the system may fail to monitor the jaw position after a jaw error occurs. This failure could result in an incorrect jaw position during treatment without generating a system interruption. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users of the affected TomoTherapy Treatment Systems should contact TomoTherapy Incorporated for instructions on how to resolve the issue. The specific serial numbers of the affected units are listed in the official recall documentation.
The recalled product
- 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)
- Manufacturer
- TomoTherapy Incorporated
Distribution
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