Hitachi SCENARIA ViewRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04580292766694), received between Jul 26, 2022 and Jul 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 12, 2022Open, Classified

   Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

   Z-1748-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionJul 26, 2022Computer Software Problem; Computer Software Problem

  ON MARCH 25, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT INVOLVING THE SCENARIA VIEW CT. IT WAS REPORTED THAT WHILE PERFORMING A SCANOGRAM, AN ERROR OCCURRED DURING A PATIENT STUDY. THE ERROR WAS DUE TO SPECIFIC SEARCH STRINGS CONTAINING LOWERCASE LETTERS ENTERED IN THE PATIENT INFORMATION FIELDS. THE IMAGES WERE NOT RECONSTRUCTED BECAUSE OF THE ERROR AND THE RAWDATA WAS NOT DISPLAYED IN THE WORKLIST. THE PATIENT WAS SUCCESSFULLY SCANNED USING ANOTHER DEVICE. THIS ISSUE WAS INITIALLY IDENTIFIED AS NON-REPORTABLE BECAUSE THERE WAS NO DEATH, PATIENT INJURY, OR CONCERN OF OVEREXPOSURE ASSOCIATED WITH THE EVENT. HOWEVER, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT THE MANUFACTURER INITIATED A RECALL ON JULY 12, 2022 TO CORRECT THIS ISSUE. AS SUCH, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102705 ↗
• MalfunctionJul 26, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT INVOLVING THE SCENARIA VIEW CT. IT WAS REPORTED THAT WHILE PERFORMING A DOUBLE SCANOGRAM, AN ERROR OCCURRED DURING A PATIENT STUDY. THE ERROR WAS DUE TO SPECIFIC SEARCH STRINGS CONTAINING LOWERCASE LETTERS ENTERED IN THE PATIENT INFORMATION FIELDS. AS A RESULT, THE IMAGES WERE NOT RECONSTRUCTED AND THE RAWDATA WAS NOT DISPLAYED IN THE WORKLIST. THE PATIENT WAS SUCCESSFULLY SCANNED USING ANOTHER DEVICE. THIS ISSUE WAS INITIALLY IDENTIFIED AS NON-REPORTABLE BECAUSE THERE WAS NO DEATH, PATIENT INJURY, OR CONCERN OF OVEREXPOSURE ASSOCIATED WITH THE EVENT. HOWEVER, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT THE MANUFACTURER INITIATED A RECALL ON (B)(6) 2022 TO CORRECT THIS ISSUE. AS SUCH, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102698 ↗
• MalfunctionJul 26, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6), 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT INVOLVING THE SCENARIA VIEW CT. IT WAS REPORTED THAT WHILE PERFORMING A HEAD SCAN, AN ERROR OCCURRED DURING A PATIENT STUDY AND THE DEVICE STOPPED. THE ERROR WAS DUE TO SPECIFIC SEARCH STRINGS CONTAINING LOWERCASE LETTERS ENTERED IN THE PATIENT INFORMATION FIELDS. THE IMAGES WERE NOT RECONSTRUCTED BECAUSE OF THE ERROR AND THE RAWDATA WAS NOT DISPLAYED IN THE WORKLIST. THE PATIENT WAS SUCCESSFULLY SCANNED USING ANOTHER DEVICE. THIS ISSUE WAS INITIALLY IDENTIFIED AS NON-REPORTABLE BECAUSE THERE WAS NO DEATH, PATIENT INJURY, OR CONCERN OF OVEREXPOSURE ASSOCIATED WITH THE EVENT. HOWEVER, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT THE MANUFACTURER INITIATED A RECALL ON (B)(6) 2022 TO CORRECT THIS ISSUE. AS SUCH, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102694 ↗