FDA DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator...
Published: July 8, 2026Recall ID: Z-2644-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Additional Source Details
| Field | Value |
|---|---|
| City | Madison |
| State | WI |
| Event id | 99083 |
| Address 1 | 1240 Deming Way |
| Address 2 | N/A |
| Code info | ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table. |
| Postal code | 53717-1954 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 292 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260616 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmAccuray Incorporated
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.