Home › Device types › IYE
Accelerator, Linear, Medical
FDA product code IYE · Class 2 · Radiology
6,436
Registered devices
3,068
Adverse events
562
Recalls
735
510(k) clearances
Devices with this code
Aquaplast RT™ — QfixFibreplast® Assure™ Open View — QfixInfinityLock™ — QfixOrfit Industries — Orfit Industries NVRIVERPOINT BRACHYTHERAPY — RIVERPOINT MEDICAL, LLCKlarity Medical — Klarity Medical Products, LLCTomoH® Treatment Delivery System — Accuray IncorporatedAquaplast RT™ — QfixHS Bite Quick Release — IT-V Medizintechnik GmbHAquaplast RT™ — QfixFibreplast™ Assure™ Open View — QfixFibreplast® — QfixNA — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHRaypilot Matching Network — Micropos Medical AB (Publ)KLARITY MEDICAL — Klarity Medical Products, LLCThermoplastic Mask — Izi Medical Products, LLCSystem HS iBEAM evo Extension PushPIN — IT-V Medizintechnik GmbHAquaplast RT™ — QfixKlarity Medical — Klarity Medical Products, LLCOrfit Industries — Orfit Industries NVKLARITY MEDICAL — Klarity Medical Products, LLCMarkRT — MATH RESOLUTIONS, LLCAccuray Precision® Treatment Planning System — ACCURAY INCORPORATEDVarian Collimator Accessories 30 cm compensator assembly — VARIAN MEDICAL SYSTEMS, INC.
Recent 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 |
| 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 |
| 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 fie |
| 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 syst |
| 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 sche |
| 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 occu |
| 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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