SMD-XGD/AR Galaxy
Our Smd Medical (Wuhan) Co., Ltd. · Model 1A · UDI-DI 06974783050023
Description
The SMD-XGD/AR Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non-overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, and b) the stereotactic localization system.
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 for technicians doin |
| 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 frame. |
| 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 previous clinical p |
| 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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