Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.According to the complaint, some patients complained about hair loss months after their examination.Examination of the received log files showed that there was no malfunction of the system that could have led to the mentioned effect.In addition, system specialists went on site to clarify the situation and test the system.The applied dose levels were in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.The system works as specified.Additional training was provided to the customer in that future working methods and settings could be found that allow a further reduction of the dose by the operator.A possible general system error, which would require corrective action of the installed base, could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.
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