Hitachi Echelon OvalRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04580292768391), received between Mar 8, 2022 and Oct 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryOct 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 21, 2022, FUJIFILM HEALTHCARE CORPORATION BECAME AWARE OF AN EVENT INVOLVING ECHELON OVAL 1.5T MRI SYSTEM THAT OCCURRED ON (B)(6) 2022. IT WAS REPORTED THAT WHILE UNDERGOING AN MRI OF THE SPINE THE PATIENT EXPERIENCED A BURNING SENSATION ON HER ARMS AND SUFFERED BLISTERING ON HER HANDS. THERE IS NO DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Blister; Burn(s)

  MAUDE report 15610781 ↗
• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON SEPTEMBER 16, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING ECHELON OVAL 1.5T MRI SYSTEM THAT OCCURRED ON (B)(6) 2022. IT WAS REPORTED THAT WHILE UNDERGOING AN MRI OF THE SPINE THE PATIENT EXPERIENCED A BURNING SENSATION ON HER ARMS AND SUFFERED BLISTERING ON HER HANDS. THERE IS NO DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Blister; Burn(s)

  MAUDE report 15477652 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 06, 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING ECHELON OVAL MRI. THE SITE REPORTED THAT A PATIENT RECEIVED A CERVICAL MRI ON (B)(6) 2020. SINCE THE RADIOLOGIST WERE NOT SATISFIED WITH THE IMAGE QUALITY, PATIENT WAS RESCANNED AT ANOTHER FACILITY, USING A DIFFERENT SYSTEM. PRIOR TO THIS PATENT WAS DIAGNOSED WITH MULTIPLE SCLEROSIS ON (B)(6) 2018 ON AN OEM SYSTEM AT ANOTHER SITE. THE PATIENT WAS SCANNED ON THE OEM SYSTEM ON (B)(6) 2021. THE RADIOLOGIST USED THIS SET OF IMAGES AND COMPARED IT TO THE ORIGINAL IMAGES FROM (B)(6) 2018. THE RADIOLOGIST AMENDED THE REPORT FROM (B)(6) 2020. PATIENT'S CONDITION AND TREATMENT INFORMATION WERE NOT RELEASED. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 13688718 ↗