Recall Z-2644-2026 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
| Date | Jul 1, 2026 (initiated Jun 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | Accuray issued an Urgent Field Safety Notice to its consignees via hand delivered letter on 6/16/2026. The notice explained the issue, risk to health, and provided the following safety instructions: "This condition may occur during collimator housing drop off or pick up while the collimator housing is positioned over the Xchange table. The system will interlock, stop motion, and display a message at the operator console to contact service. If an interlock occurs: (1) remove the patient from the treatment room before troubleshooting, (2) do not initiate treatment robot motion from the in-roo |
| Quantity | 292 units |
| Distribution | 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, Net |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170788 | CyberKnife Treatment Delivery System Accuray Incorportaed, Apr 11, 2017 |