Reflexion Medical Radiotherapy System
REFLEXION MEDICAL, INC. · Model RXM1000 · UDI-DI 00860003983805
Description
The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT (kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It can achieve a nominal dose rate of 850 cGy/min.
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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