Recall
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic…
Accuray Incorporated · 22 Nov 2016
- Status
- Recall terminated
- Why, in the FDA's words
- “Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6.”
- Recall began
- 22 Nov 2016
- 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.