SCENARIA ViewRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04573596200544), received between Jul 21, 2022 and Jul 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022 FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING SCENARIA VIEW CT. IT WAS REPORTED THAT ONE PATIENT WAS SCANNED MULTIPLE TIMES ON 2 DIFFERENT DEVICES AT THE SAME LOCATION OVER THE PERIOD OF TWO DAYS. THE ERROR OCCURRED WHILE SCANNING PATIENT INFORMATION THAT CONTAINED SPECIFIC WORDS. BECAUSE OF THE ERROR, IMAGES WEREN'T RECONSTRUCTED AND RAW DATA WAS NOT DISPLAYED. DUE TO THIS, ONE PATIENT WAS SCANNED MULTIPLE TIMES. THE PATIENT WAS SUCCESSFULLY SCANNED ON ANOTHER DEVICE (REPORTED UNDER 1528028-2022-00050), BUT ON (B)(6) 2022 IT WAS CONFIRMED THAT THE PATIENT RECEIVED 106.78 MSV IN RADIATION ACROSS THE TWO DAYS. FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT THE MANUFACTURER HAS INITIATED A RECALL ON JULY 12, 2022 TO CORRECT THIS ISSUE. THERE WAS NO DEATH OR INJURY REPORTED WITH THIS EVENT. THE OTHER SYSTEM INVOLVED IN THIS INCIDENT IS BEING REPORTED UNDER 1528028-2022-00050.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074318 ↗
• MalfunctionJul 21, 2022Computer Software Problem; Computer Software Problem

  ON MAY 08, 2022 FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING SCENARIA VIEW CT. IT WAS REPORTED THAT ONE PATIENT WAS SCANNED MULTIPLE TIMES ON 2 DIFFERENT DEVICES AT THE SAME LOCATION OVER THE PERIOD OF TWO DAYS. THE ERROR OCCURRED WHILE SCANNING PATIENT INFORMATION THAT CONTAINED SPECIFIC WORDS. BECAUSE OF THE ERROR IMAGES WEREN'T RECONSTRUCTED AND RAWDATA WAS NOT DISPLAYED. DUE TO THIS ONE PATIENT WAS SCANNED MULTIPLE TIMES. THE PATIENT WAS SUCCESSFULLY SCANNED ON THIS DEVICE, BUT ON (B)(6) 2022 IT WAS CONFIRMED THAT THE PATIENT RECEIVED 106.78 MSV IN RADIATION ACROSS THE TWO DAYS. FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED THAT THE MANUFACTURER HAS INITIATED A RECALL ON JULY 12, 2022 TO CORRECT THIS ISSUE. THERE WAS NO DEATH OR INJURY REPORTED WITH THIS EVENT. THE OTHER SYSTEM INVOLVED IN THIS INCIDENT IS BEING REPORTED UNDER 1528028-2022-00051.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074305 ↗