Home › Device types › LHN
System, Radiation Therapy, Charged-Particle, Medical
FDA product code LHN · Class 2 · Radiology
239
Registered devices
137
Adverse events
58
Recalls
93
510(k) clearances
Devices with this code
SDX System — DYN'RZephyr Patient Positioning and Transfer System — Diacor, Inc.ProBeam 360 Proton Therapy System - Rotaiting Gantry — Varian Medical Systems Particle Therapy GmbH & Co. KGInfinityLock™ — QfixEncompass™ — QfixZephyr Patient Positioning and Transfer System — Diacor, Inc.BoS™ AirShuttle™ — QfixMcLaren Range Shifter (15x15) (TR2) — McLaren Health Care CorporationAirShuttle Locating Bar — QfixNA — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHSNC350p (TNC) — SUN NUCLEAR CORP.SDX System — DYN'RSDX System — DYN'REncompass™ SRS Fibreplast™ System — QfixMyoStrain — MYOCARDIAL SOLUTIONS, INC.iPlan RT Image — Brainlab SESDX System — DYN'RPROBEAT — HITACHI HIGH-TECH CORPORATIONPinPoint — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHStradivarius™ — QfixSRS MR Adapter — QfixI2C (IBA Image-Guided Therapy Console) — Ion Beam Applications SAZiFix™ — QfixEncompass™ SRS Fibreplast™ System — Qfix
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-06 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Software anomaly in the patient positioning system may result in positional discrepancy. |
| 2026-02-06 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Software anomaly in the patient positioning system may result in positional discrepancy. |
| 2026-02-03 | Ion Beam Applications S.A. | It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS do |
| 2024-07-10 | Ion Beam Applications S.A. | Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues |
| 2024-07-08 | Ion Beam Applications S.A. | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime |
| 2024-05-27 | Hitachi America, Ltd., Particle Therapy Division | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display C |
| 2024-05-27 | Hitachi America, Ltd., Particle Therapy Division | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display C |
| 2024-05-27 | Hitachi America, Ltd., Particle Therapy Division | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display C |
| 2024-05-10 | Ion Beam Applications S.A. | Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances |
| 2024-03-04 | Ion Beam Applications S.A. | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. |
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