Accuray TomoHD System Recalled for Uncontrolled Couch Movement
Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.
What this means for you
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 high-risk medical device with a mechanical defect that could cause injury, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 118 units of the TomoHD(R) System, Model Number 1018283, due to a defect involving 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. The specific serial numbers affected are listed in the official recall documentation. This defect poses a risk of unintended movement of the patient couch during treatment.
Healthcare facilities should contact Accuray Incorporated for instructions on how to address this issue. Patients who have received treatment on these devices should consult their healthcare provider for guidance.
The recalled product
- Product
- TomoHD(R) System, Model Number 1018283 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 target
- Manufacturer
- Accuray Incorporated
- Hazard
- Affected units
- 118
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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