Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with a documented mechanism for serious injury (falling hardware in a treatment environment). Although no injuries are reported in the source, the structural risk—a collimator potentially falling from the treatment apparatus—meets the Severe criterion for risk-of-harm products in medical device contexts.
Plain-English summary
Accuray Incorporated is recalling 292 Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer running software version 11.X and higher. The recalled systems are distributed nationwide across the United States and internationally.
In certain cases, the 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, creating a risk of injury.
Patients and healthcare facilities currently using affected Cyberknife systems should contact Accuray Incorporated for specific instructions. The company will provide guidance on system status verification and necessary corrective actions to prevent collimator release during treatment or maintenance.
The recalled product
- Product
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Manufacturer
- Accuray Incorporated
- Affected units
- 292
Distribution
Distributed nationwide across the United States.
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