Recall
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
Accuray Inc · 9 April 2008
- Status
- Recall terminated
- Why, in the FDA's words
- “Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.”
- Recall began
- 9 April 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.