Accuray CyberKnife Robotic Recall for Potential Gun Box Mounting Bracket Failure
Accuray is recalling CyberKnife Robotic systems because the gun box mounting bracket may fail, allowing the gun box to fall and contact a patient.
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 3/5 (High).
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-harm product where the gun box could physically contact a patient, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Accuray Incorporated is recalling the CyberKnife Robotic Radiosurgery System, specifically catalog/part numbers 032000 and 033000. The recall involves 226 units distributed worldwide, including the United States, Canada, and numerous international locations.
The recall is due to a potential defect in the gun box mounting bracket. The bracket may fail to support the weight of the gun box when it is in a vertical or inverted position. If this failure occurs, the gun box may become loose and could come into contact with a patient.
The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and…
- Manufacturer
- Accuray Incorporated
- Affected units
- 226
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 (1)
- Catalog/part numbers 032000 and 033000
Distribution
Distributed nationwide across the United States.
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