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BIONIX RADIATION THERAPY
Bionix Radiation Therapy, LLC · Model EMRT-8350 · UDI-DI 00817740020249
IYE
Prescription
10
510(k) clearances
3,068
Adverse events (20 deaths)
562
Recalls
115
Facilities
Description
2.4MM HEAD & SHOULDER VERSAFRAME
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2025-04-01 | IBA Dosimetry GmbH | Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.