Model Number 1060000 |
Device Problem
Application Program Problem: Dose Calculation Error (1189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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In previous sw versions, the last recorded couch position represented the position of the couch before treatment started.In radixact 2.X, the introduction of multiple delivery segments changed the meaning of the last recorded couch position to include any additional couch offsets applied during treatment.The shifts applied after the start of treatment will proportionally impact the effect on dose calculation; the offsets are expected to be in the range of 5mm.Visualizations of incorrect dose will be seen in preciseart but there is a hazard of overdose/underdose that could occur if the user decided to replan the patient and tried to compensate for the differences when replanning.A fix is being investigated.
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Event Description
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The preciseart software is used in conjunction with the radixact 2.X software and it was found that adaptive process was using actual registration offsets as opposed to the accepted offsets based on motion tracking move in y values.
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Manufacturer Narrative
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The initial report was provided based upon a preliminary analysis of the anomaly and associated risk.Upon further investigation by accuray, the anomaly was determined that it does not significantly impact dose accuracy and does not represent a serious risk to patients.
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Event Description
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Follow-up report.
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Search Alerts/Recalls
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