Hitachi SupriaRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04580292766601), received between Aug 2, 2022 and Aug 2, 2022 — classified as 2 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1749-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-1750-2022 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionAug 2, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT INVOLVING THE SUPRIA TRUE64 WHOLE-BODY X-RAY CT SYSTEM. THE EVENT DESCRIBED IN THIS REPORT OCCURED TWICE IN ONE DAY DURING TWO DIFFERENT PATIENT STUDIES. THIS REPORT ADDRESSES THE SECOND OF THE TWO EVENTS. 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. 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 15154118 ↗
• MalfunctionAug 2, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT INVOLVING THE SUPRIA TRUE64 WHOLE-BODY X-RAY CT SYSTEM. THE EVENT DESCRIBED IN THIS REPORT OCCURED TWICE IN ONE DAY DURING TWO DIFFERENT PATIENT STUDIES. THIS REPORT ADDRESSES THE FIRST OF THE TWO EVENTS. 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. 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 15154116 ↗