FDA recall Z-1023-2025

Accuray Incorporated · Class II · device

Product

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Reason for recall

Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Completed
Initiation date
2024-12-23
Report date
2025-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1023-2025