Home › Device types › LHN
System, Radiation Therapy, Charged-Particle, Medical
FDA product code LHN · Class 2 · Radiology
226
Registered devices
136
Adverse events
58
Recalls
92
510(k) clearances
Devices with this code
InfinityLock™ — QfixNA — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHEncompass™ — QfixProBeam Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KGZephyr Patient Positioning and Transfer System — Diacor, Inc.Zephyr Patient Positioning and Transfer System — Diacor, Inc.NA — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHAirShuttle Transfer Handle — QfixZephyr Patient Positioning and Transfer System — Diacor, Inc.X-ray Imaging System (XIS) — EhmetDx LLCInfinityLock™ — QfixEncompass™ SRS Fibreplast™ System — QfixPinPoint — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHSemiflex — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHStradivarius™ — QfixZiFix™ — QfixEncompass™ SRS Fibreplast™ Anterior Mask — QfixApplicator Clamp Holder — QfixSNC600c (BNC) — SUN NUCLEAR CORP.Zephyr Patient Positioning and Transfer System — Diacor, Inc.CinemaVision — RESONANCE TECHNOLOGY, INC.Zephyr Patient Positioning and Transfer System — Diacor, Inc.Proteus 235 — Ion Beam Applications SAPinPoint — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
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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