Recall
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision…
Accuray Inc · 22 June 2009
- Status
- Recall terminated
- Why, in the FDA's words
- “Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.”
- Recall began
- 22 June 2009
- Company
- Accuray Inc
- Device type
- Product code (IYE)
- Concerns
- K072504
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.