Recall
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Accuray Incorporated · 13 Jan 2014
- Status
- Recall terminated
- Why, in the FDA's words
- “Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.”
- Recall began
- 13 Jan 2014
- Company
- Accuray Incorporated
- Device type
- Product code (IYE)
- Concerns
- K122137
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.