Cases of lost patient treatment data have been reported to bebig.During system shutdown of the saginovacontrol software, valid data might be rejected and lost due to an error in the exception handling procedure by the software.The error can potentially affect every saginovasystem.Data that is already stored on the system and shown after system startup is not affected and remains available.Loss of the information about performed maintenance, quality assurance check or treatment fraction may cause inconsistency in the documentation and confusion of the user.This could result in the delivery of the wrong treatment session or repeated treatment of already delivered fractions and possibly cause adverse health consequences.The resolution of the issue will be available with the next saginovasoftware release scheduled for early july.Valid data is available as long as the system is not shut down and must be printed or saved as pdf files immediately after execution of the treatment procedure or maintenance check.Furthermore the user must check that the treatment fraction number during fraction import is consistent with the treatment plan and previous treatment reports.All saginova users must be informed that they have to comply with the preventative user actions as described in detail in the following section until the problem has been resolved with the new software release.Recommended user action i: print all quality assurance, maintenance and treatment reports directly after they have been generated or save all respective pdf-files on a secure file system, which is approved to store patient data.Recommended user action ii: double check the treatment fraction number during fraction import on the saginovacontrol console with the respective treatment plan from sagiplanand all existing treatment reports from saginova in case if the fraction numbers of newly imported fractions don't overlap with existing treatment reports, the treatment can be performed followed by recommended user action i.In case the fraction numbers of newly imported fractions do overlap with existing treatment reports, the import should be rejected and the following steps should be followed re-import the fraction(s) missing in the system.Import the fraction(s) that need to be treated next.Delete the fractions generated, as they are shown with a wrong status.Treat the fraction(s) as scheduled and follow by recommended user action i.
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