CyberKnife® M6™ Systems
Accuray Incorporated · Model 053401-M-000 · UDI-DI 00811376030467
Description
CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | PTW FREIBURG | When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorr |
| 2026-06-16 | Accuray Incorporated | 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 i |
| 2026-06-16 | Accuray Incorporated | 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 i |
| 2026-05-21 | Elekta, Inc. | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| 2025-12-14 | Elekta, Inc. | Due to a manufacturing issue and electrical grounding of systems. |
| 2025-12-10 | Elekta, Inc. | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or l |
| 2025-10-09 | C-RAD POSITIONING AB | Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the |
| 2025-09-17 | ELEKTA SOLUTIONS AB | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. |
| 2025-07-25 | Zap Surgical Systems | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat |
| 2025-04-22 | C-RAD POSITIONING AB | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. |
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