Accuray Hi-Art System Recalled for Uncontrolled Couch Movement
Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.
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 and involves a structural defect in a medical device used for radiation therapy, which poses a risk of significant injury.
Plain-English summary
Accuray Incorporated is recalling 250 units of the Hi-Art(R) System, Model Number H-000-0003. These systems are intended for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues.
The recall is due to uncontrolled couch Z-axis movement (descent). The affected units were distributed worldwide. Specific serial numbers for the 250 affected units are listed in the official recall documentation.
Healthcare facilities should contact Accuray Incorporated for instructions on how to address this issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other…
- Manufacturer
- Accuray Incorporated
- Affected units
- 250
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Accuray Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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