syngo.via 11461857Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869259802), received between Apr 26, 2021 and Apr 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021Computer Software Problem; Computer Software Problem

  THE REPORTED ISSUE WAS IDENTIFIED INTERNALLY BY SIEMENS R&D DEPARTMENT ON THE SYNGOVIA SYSTEMS WITH VERSION VB50 IN THE LUNGCAD NAVIGATION TOOL. AN INCORRECT NODULE GETS CORRECTED IN THE LUNGCAD NAVIGATION TOOL AFTER ACCEPTING THE CURRENTLY EDITED NODULE FOR THE 2ND TIME. CORRECTION FOCUS DOES NOT SWITCH TO THE NEW NODULE AND AFFECTS PREVIOUS NODULE, ON WHICH CORRECTION PEN WAS INVOKED. AS A RESULT, INCORRECT INFORMATION MAY CONTRIBUTE TO MEDICAL DIAGNOSIS AS A DIFFERENT NODULE QUANTIFICATION IS CHANGED AND IT COULD LEAD TO A WRONG NODULE ASSESSMENT. WRONG NODULE ASSESSMENT MAY CONTRIBUTE TO INADEQUATE CLINICAL PATIENT MANAGEMENT. THE DESCRIBED ISSUE IS DETECTIBLE TO THE USER; HOWEVER, THE USER MAY NOT REALIZE THAT VALUES HAD BEEN CHANGED FOR THE ACCEPTED FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728405 ↗