United StatesCyberKnife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer (all CyberKnife systems running software version 11.X and higher that utilize the Exchange Table) are affected. They were recalled because in certain cases a collimator may not fully dock, triggering a system interlock and, if personnel enter the treatment room and initiate motion with the in‑room control pendant, the collimator may release and fall from the housing. Owners should check whether their system matches the identified software/version and configuration.
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 Cyberknife systems running software version 11.X and higher 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 - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
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)