Recall
CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. Accuray Incorporated, Sunnyvale, CA. Treatment…
Accuray Incorporated · 16 Jan 2012
- Status
- Recall terminated
- Why, in the FDA's words
- “An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.”
- Recall began
- 16 Jan 2012
- 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.