FDA Device recall Z-1023-2025
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
- FDA Device
- Class II
- completed
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System by Accuray, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1023-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-12-23 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accuray |
| Distribution | US |
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
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.
Identifiers
| code_info | This issue affects all CyberKnife Treatment Delivery Systems using the STC. UDI-DI Pending. Unit numbers: C0014 C004…This issue affects all CyberKnife Treatment Delivery Systems using the STC. UDI-DI Pending. Unit numbers: C0014 C0042 C0047 C0056 C0059 C0064 C0066 C0071 C0074 C0076 C0077 C0085 C0086 C0089 C0091 C0092 C0093 C0099 C0100 C0101 C0115 C0117 C0119 C0131 C0137 C0140 C0162 C0166 C0168 C0172 C0173 C0174 C0177 C0181 C0182 C0186 C0197 C0200 C0205 C0234 C0236 C0239 C0240 C0241 C0246 C0254 C0258 C0259 C0263 C0266 C0268 C0270 C0271 C0274 C0277 C0280 C0282 C0286 C0289 C0291 C0292 C0293 C0297 C0298 C0299 C0300 C0301 C0302 C0303 C0304 C0305 C0306 C0309 C0310 C0312 C0313 C0317 C0319 C0321 C0325 C0328 C0331 C0339 C0343 C0345 C0351 C0352 C0353 C0355 C0356 C0357 C0360 C0363 C0365 C0368 C0369 C0370 C0373 C0377 C0380 C0381 C0382 C0383 C0384 C0386 C0388 C0390 C0394 C0396 C0397 C0399 C0401 C0402 C0403 C0405 C0411 C0413 C0416 C0417 C0420 C0423 C0424 C0429 C0430 C0432 C0435 C0436 C0438 C0440 C0441 C0444 C0446 C0447 C0451 C0457 C0458 C0460 C0464 C0467 C0470 C0473 C0476 C0479 C0480 C0482 C0484 C0485 C0487 C04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1023-2025%22
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