United StatesCyberknife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer (linear accelerator), specifically all systems with software version 11X that utilize the Exchange Table, is affected. It was recalled because a collimator may not fully dock, which can trigger a system interlock preventing motion from the operator console and, if personnel enter the treatment room and initiate motion with the in‑room control pendant, the collimator may release and fall from its housing.
What's being recalled
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Recalling firm: Accuray Incorporated, Madison, WI, United States.
How to identify it
All systems prior with software version 11X that utilize the Exchange Table
The hazard
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)