CyberKnife Treatment System: Internal Snap Ring Detachment Risk
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
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: This is a risk-of-harm medical device (stereotactic radiosurgery system) with potential mechanical failure that could compromise treatment safety and precision. The source text reports no illnesses or injuries, and it is classified as FDA Class II, placing it at score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The CyberKnife Treatment Delivery System (REF 0660000), manufactured by Accuray Incorporated, is used for image-guided stereotactic radiosurgery and precision radiotherapy. The system is affected by a mechanical failure in which snap rings may become partially or completely detached from shafts within the internal mechanism.
When snap rings are removed or damaged, uncontrolled rotation may occur on the left and right roll axes. This mechanical failure could affect the safety and precision of radiotherapy treatments.
The recall affects 212 CyberKnife Treatment Delivery Systems worldwide, including distribution across the United States. Affected units use the STC component.
The recalled product
- Product
- CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
- Manufacturer
- Accuray Incorporated
- Hazard
- snap-ring-detachment
- uncontrolled-rotation
Distribution
Distributed nationwide across the United States.
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