Recall
CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and…
Accuray Incorporated · 7 Nov 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.”
- Recall began
- 7 Nov 2011
- Company
- Accuray Incorporated
- 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.