Recall
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and…
Accuray Incorporated · 12 Sept 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged which allowed rotation and subsequent descent of the assembly.”
- Recall began
- 12 Sept 2011
- Company
- Accuray Incorporated
- Device type
- Product code (IYE)
- Concerns
- K102650
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.