SMD Galaxy RTx
Our Smd Medical (Wuhan) Co., Ltd. · Model 3A · UDI-DI 06974783050009
Description
The device contains 30 Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimator and a blocking position. The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient’s head is immobilized in a head frame which has been fitted prior to the commencement of treatment. The entire system consists of a) the gamma ray treatment unit, and b) the stereo-tactic 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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