Accuray TomoHDA System Recalled for Uncontrolled Couch Movement
Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.
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 the hazard involves uncontrolled movement of a heavy medical device component (couch) which poses a significant risk of injury to patients or staff.
Plain-English summary
Accuray Incorporated is recalling 87 units of the TomoHDA(R) System, Model Number 1018286, due to a defect that allows for uncontrolled couch Z-axis movement (descent). The TomoTherapy treatment 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 covers units distributed worldwide with specific serial numbers listed in the agency documentation. This defect poses a risk of injury to patients or operators if the treatment couch descends unexpectedly during use.
Healthcare facilities and users of these systems should contact Accuray Incorporated for instructions on how to address the defect and ensure patient safety.
The recalled product
- Product
- TomoHDA(R) System, Model Number 1018286 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
- 87
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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