Accuray TomoH System Recalled for Uncontrolled Couch Movement
Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.
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 involves a structural defect in a medical device that can cause physical injury to patients, meeting the criteria for a Severe rating (score 4) due to significant injury risk.
Plain-English summary
Accuray Incorporated is recalling 29 units of the TomoH(R) System, Model Number 1018284. The recall is due to a defect that can cause uncontrolled movement of the patient couch in the Z-axis (downward descent). The TomoH System is a medical device used for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues.
The affected units were distributed worldwide. The specific serial numbers for the 29 recalled units are listed in the official recall documentation. This defect presents a risk of physical injury to patients if the couch descends unexpectedly during treatment.
Healthcare facilities and users of the TomoH System should stop using the affected units immediately and contact Accuray Incorporated for instructions on repair or replacement. Patients who have received treatment on these devices should consult their healthcare providers if they have concerns.
The recalled product
- Product
- TomoH(R) System, Model Number 1018284 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
- 29
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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