Home › Device types › IWB
System, Radiation Therapy, Radionuclide
FDA product code IWB · Class 2 · Radiology
150
Registered devices
214
Adverse events
29
Recalls
48
510(k) clearances
Devices with this code
Leksell Gamma Knife Icon — Elekta Instrument ABExtend Frame system — Elekta Instrument ABGammaBeam — Best Theratronics LtdLeksell Gamma Knife Perfexion/Icon — Elekta Instrument ABGammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCISORAD Detector, 6-12MV (-) 1.5m — SUN NUCLEAR CORP.Leksell Gamma Knife Perfexion/Icon — Elekta Solutions ABLeksell Gamma Knife Icon — Elekta Instrument ABClarity® — Elekta Solutions ABLeksell Gamma Knife Perfexion — Elekta Instrument ABLeksell Gamma Knife Perfexion/Icon — Elekta Solutions ABGammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCISORAD Detector, 15-25MV (-) 3m — SUN NUCLEAR CORP.GammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCGammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCGammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCExtend Frame system — Elekta Instrument ABGammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLCClarity® — Elekta Solutions ABExtend Frame system — Elekta Instrument ABClarity® — Elekta Solutions ABLeksell Gamma Knife Esprit — Elekta Solutions AB6-12 MV ISORAD Detector (3m Cable) — SUN NUCLEAR CORP.GammaPod™ Breast Immobilization and Localization System — XCISION MEDICAL SYSTEMS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Elekta, Inc. | Due to adapter not being properly aligned or locked in place. |
| 2023-11-30 | Xcision Medical Systems, LLC | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected |
| 2019-07-03 | Xcision Medical Systems, LLC | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
| 2018-06-27 | Elekta Instrument AB | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. |
| 2017-05-23 | Elekta, Inc. | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety |
| 2016-04-19 | Elekta, Inc. | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate fra |
| 2015-06-01 | Elekta, Inc. | Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. |
| 2014-10-06 | Elekta, Inc. | Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame. |
| 2011-06-23 | Elekta, Inc. | There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches |
| 2011-05-26 | Elekta, Inc. | Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient. |
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