Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Electric Shock Risk
Accuray is recalling 115 CyberKnife Robotic Radiosurgery Systems (models G3, G4, VSI) due to a potential electric shock hazard during maintenance.
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 risk of electric shock, which is a risk-of-harm product issue. The source text does not report any injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 115 units of the CyberKnife Robotic Radiosurgery System, specifically models G3, G4, and VSI. The recall is due to a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply located at the back of the modulator cabinet.
The affected devices were distributed worldwide, including in the United States and various foreign countries. The source text does not specify the exact number of patients treated or any reported injuries or illnesses associated with this defect.
Healthcare facilities and users should contact Accuray Incorporated for instructions on how to address this safety issue. The recall is limited to the specific serial numbers listed in the agency's documentation.
The recalled product
- Product
- CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body
- Manufacturer
- Accuray Incorporated
- Hazard
- Affected units
- 115
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- models: G3
- G4
Distribution
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