Recall
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided…
Accuray Inc · 14 Nov 2008
- Status
- Recall terminated
- Why, in the FDA's words
- “System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.”
- Recall began
- 14 Nov 2008
- 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.