Recall
CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision…
Accuray Inc · 28 Oct 2010
- Status
- Recall terminated
- Why, in the FDA's words
- “If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.”
- Recall began
- 28 Oct 2010
- Company
- Accuray Inc
- Device type
- Product code (IYE)
- Concerns
- K091999
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.