Device Problem
Computer Software Problem (1112)
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Patient Problem
Radiation Overdose (1510)
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Event Date 09/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.
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Event Description
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A third party supplier to a customer reported that the wedge fields were treated as open fields.Based on the available information mistreatment to a patient could potentially result in serious clincial outcome.
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Event Description
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A third party supplier to a customer reported that the wedge fields were treated as open fields.Based on the available information mistreatment to a patient could potentially result in serious clinical outcome.Elekta physics assessed that the total overdose to the patient was ~25% per day and ~25% over the course of the treatment.
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Manufacturer Narrative
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Event-patient information updated.H10 updated: the investigation found if there are no wedge ids included in the dicom rt plan sent from the tps the field in mosaiq will be created with no wedge.Mosaiq is dependent on the presence of the wedge id to assign a wedge to a beam at the time of plan promotion, regardless of the presence of other wedge indicators (e.G.Number of wedges or wedge position).No warnings are presented if wedge ids are not present.If not discovered, it is possible that fields planned with wedges can be delivered without the wedge.Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.The root cause was that the wedge label was not defined in dicom plan, therefore mosaiq does not import wedge information at all.A recall has been released as the corrective action for the defect identified in mosaiq.Fca-ims-0027 was notified to the authorities on (b)(6)2018.An ifsn 371-01-msq-013 was released to all affected customer sites on 13 december 2018.Three patches have been released for implementation in the field as follows: ifsm 371-02-msq-013 released date(b)(6)2019 - mosaiq version 2.64.278 (sp11) ifsm 371-02-msq-014 released date (b)(6)2019 - mosaiq version 2.70.89 ifsm 371-02-msq-015 released date (b)(6)2019 - mosaiq version 2.65.249 (sp2) a further patch will be released for mosaiq versions lower than 2.64 which is estimated june 2019.
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Search Alerts/Recalls
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