LungVision System CoreRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290017652085), received between Jul 27, 2022 and Dec 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE THE COMPUTER POWER WAS REPEATEDLY LOST. THE USER LOST LESION IMAGE AND LOCATION AND COULD NOT CONTINUE SAMPLING FROM THE ACCURATE LOCATION. BIOPSIES WERE TAKEN BUT THE CASE WAS EVENTUALLY ABORTED AND NOT FINISHED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914881 ↗
• MalfunctionJul 27, 2022Computer Software Problem; Computer Software Problem

  AFTER SUCCESSFULLY COMPLETING THE FIRST PROCEDURE OF THE DAY, DR. (B)(6) WAS WAITING FOR THE PROCEDURE APPLICATION TO FINISH PROCESSING THE CASE DATA AND CLOSE. WHILE WAITING FOR THIS PROCESS TO COMPLETE THE CLINICIAN PERFORMED THE HARD SHUTDOWN OF THE TABLET AND THEN RESTARTED IT WITHOUT RESTARTING THE WHOLE SYSTEM, INCLUDING TABLET AND MAIN UNIT, AS RECOMMENDED BY VENDOR. THIS CAUSED THE TABLET AND MAIN UNIT TO BECOME OUT OF SYNC IN THE SUBSEQUENT TWO CASES THAT DAY. DURING CASES 2 AND 3, FALSE CABT ERROR MESSAGES WERE DISPLAYED DURING MAIN CARINA REGISTRATION. THE CLINICIAN WAS ABLE TO CONTINUE THROUGH THE ERROR MESSAGES AND PROCEEDED TO MARK THE MAIN CARINA. AFTER THIS, THE LESION OVERLAY WAS INITIALLY DISPLAYED ON THE FLUORO VIDEO DURING PROCEDURE; HOWEVER, AS SOON AS THE CLINICIAN MADE HIS FIRST ISOCENTER ADJUSTMENT, THE OVERLAY DISAPPEARED AND NEVER CAME BACK. HE TRIED MULTIPLE VIEWING ANGLES IN AN ATTEMPT TO GET THE OVERLAY TO REAPPEAR BUT IT DID NOT. THUS, DUE TO THE SOFTWARE ERROR MESSAGES AND THE INABILITY TO TROUBLESHOOT, THE CLINICIAN ABANDONED THE USE OF THE LUNGVISION SYSTEM AND UTILIZED THE MONARCH AURIS SYSTEM TO COMPLETE THE PROCEDURE. THOUGH THE DEVICE SOFTWARE M

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15114368 ↗
• MalfunctionJul 27, 2022Computer Software Problem; Computer Software Problem

  AFTER SUCCESSFULLY COMPLETING THE FIRST PROCEDURE OF THE DAY, DR. HOGARTH WAS WAITING FOR THE PROCEDURE APPLICATION TO FINISH PROCESSING THE CASE DATA AND CLOSE. WHILE WAITING FOR THIS PROCESS TO COMPLETE THE CLINICIAN PERFORMED THE HARD SHUTDOWN OF THE TABLET AND THEN RESTARTED IT WITHOUT RESTARTING THE WHOLE SYSTEM, INCLUDING TABLET AND MAIN UNIT, AS RECOMMENDED BY VENDOR. THIS CAUSED THE TABLET AND MAIN UNIT TO BECOME OUT OF SYNC IN THE SUBSEQUENT TWO CASES THAT DAY. DURING CASES 2 AND 3, FALSE CABT ERROR MESSAGES WERE DISPLAYED DURING MAIN CARINA REGISTRATION. THE CLINICIAN WAS ABLE TO CONTINUE THROUGH THE ERROR MESSAGES AND PROCEEDED TO MARK THE MAIN CARINA. AFTER THIS, THE LESION OVERLAY WAS INITIALLY DISPLAYED ON THE FLUORO VIDEO DURING PROCEDURE; HOWEVER, AS SOON AS THE CLINICIAN MADE HIS FIRST ISOCENTER ADJUSTMENT, THE OVERLAY DISAPPEARED AND NEVER CAME BACK. HE TRIED MULTIPLE VIEWING ANGLES IN AN ATTEMPT TO GET THE OVERLAY TO REAPPEAR BUT IT DID NOT. THUS, DUE TO THE SOFTWARE ERROR MESSAGES AND THE INABILITY TO TROUBLESHOOT, THE CLINICIAN ABANDONED THE USE OF THE LUNGVISION SYSTEM AND UTILIZED THE MONARCH AURIS SYSTEM TO COMPLETE THE PROCEDURE. THOUGH THE DEVICE SOFTWARE

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15114135 ↗