Hitachi OasisRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04580292768186), received between Jun 14, 2017 and Jul 1, 2026 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  ON 05/29/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. THE CUSTOMER REPORTED THAT ANOTHER PATIENT COMPLAINED OF HEATING AND AN ELECTRICAL SHOCK FEELING IN HER RIGHT HAND AFTER RUNNING THE SCANOGRAM. THE PATIENT #3 COMPLETED BOTH STUDIES, LUMBAR THEN HEAD. THE PATIENT #3 DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION. FUJI ENGINEER HAS COMPLETED THE TRANSMITTER TESTING AND TEMPERATURE TESTING. ON 06/26/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION DETERMINED NOT TO SUBMIT AN IMPORTER MDR SINCE THE PATIENT #3 COMPLETED BOTH STUDIES. DUE TO THE COMPLAINT OF HEATING AND AN ELECTRICAL SHOCK FEELING IN PATIENT'S RIGHT HAND, FUJIFILM HEALTHCARE AMERICAS CORPORATION HAS DETERMINED ON 07/01/2026 TO SUBMIT AN IMPORTER MDR OF THIS EVENT IN AN ABUNDANCE OF CAUTION. RELATED: PATIENT 1 - 1000513161-2026-00012. PATIENT 2 - 1000513161-2026-00013. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

  Patient problems: Discomfort

  MAUDE report 25685762 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  ON 05/29/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. THE CUSTOMER REPORTED THAT A PATIENT COMPLAINED OF PAIN IN THEIR LEFT HANDS WHEN MOVED INTO THE GANTRY. THE PATIENT #2 HAD A FOLLOW UP XRAY OF LEFT HAND, "BB AT THE BASE OF THE FOURTH PROXIMAL PHALANX. NO BONY INJURY IDENTIFIED."BUT DID NOT COMPLETE THE STUDY THAT THEY WERE ORIGINALLY SCHEDULED. THE PATIENT #2 COMPLETED LT SHOULDER(HEAD FIRST), DID NOT COMPLETE KNEE SCAN. FUJI ENGINEER HAS COMPLETED THE TRANSMITTER TESTING AND TEMPERATURE TESTING. DUE TO THE UNCONFIRMED FOLLOW UP TO COMPLETE THE ORIGINALLY SCHEDULED STUDY, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. RELATED: PATIENT 1 - 1000513161-2026-00012. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

  Patient problems: Discomfort

  MAUDE report 25641252 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  ON 05/29/2026, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. THE CUSTOMER REPORTED THAT A PATIENT COMPLAINED OF PAIN IN THEIR LEFT HANDS WHEN MOVED INTO THE GANTRY. THE PATIENT #1 DID NOT SEEK ANY FURTHER MEDICAL ATTENTION BUT DID NOT COMPLETE THE STUDY THAT THEY WERE ORIGINALLY SCHEDULED. FUJI ENGINEER HAS COMPLETED THE TRANSMITTER TESTING AND TEMPERATURE TESTING. DUE TO THE UNCONFIRMED FOLLOW UP TO COMPLETE THE ORIGINALLY SCHEDULED STUDY, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. RELATED: PATIENT 2 - 1000513161-2026-00013. REF: FUJIFILM HEALTHCARE AMERICAS CORPORATION COMPLAINT # (B)(4).

  Patient problems: Discomfort

  MAUDE report 25640975 ↗
• InjuryNov 19, 2025Unintended System Motion; Failure to Advance; Difficult to Advance; Physical Resistance/Sticking; Unintended System Motion; Failure to Advance; Difficult to Advance; Physical Resistance/Sticking

  ON 10/27/2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN ISSUE WITH SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT THE PATIENT TABLE IS STICKING MOVING IN AND OUT. THE TABLE IS GOING IN AND THEN STOPPING. WHEN THEY PRESS THE "SET" BUTTON THEY SAID THAT THE TABLE GOES 1-2" FURTHER THAN IT SHOULD. CUSTOMER TRIED BRINGING THE TABLE "OUT" AND IT WOULD COME OUT 1" AND THEN GO INTO RELEASE. THE CUSTOMER HAD TO REPEAT THIS PROCESS MULTIPLE TIMES TO GET IT TO COME OUT TO VERIFY THAT THE TABLE EXTENSION LATCH WAS NOT ENGAGED. CUSTOMER REPORTED HAVING A PATIENT ON THE TABLE BEING SEEN FOR AN MRI OF THE BREAST. THE MALFUNCTION CAUSED THE TABLE TO JERK THE PATIENT FORWARD WHILE ENTERING THE MANGET. PATIENT STATED TO THE CUSTOMER THAT THEIR RIBS WERE BROKEN. THE TABLE WENT IN FURTHER THAN THE "SET" BUTTON, BUT THE PATIENT FELT CRUSHED AS THEY WERE INBETWEEN THE TOP OF THE MAGNET AND THE COIL. THE PATIENT HAS A BUCKLE FRACTURE OF THE 6TH ANTERIOR RIB. THE FRACTURE WAS NOT PRESENT PRIOR TO THE PATIENTS MRI SCAN. PATIENT CONFIRMED TO BE IN TREMENDOUS PAIN. PATIENT COMPLAINED FURTHER THAT THE MACHINE CRUSHED HER BACK AND STERNUM WHEN IT JERKED HER INSIDE. PATIENT IN TAKING TYLE

  Patient problems: Bone Fracture(s); Crushing Injury

  MAUDE report 23597519 ↗
• MalfunctionFeb 25, 2025Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  ON 01/31/2025, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT THE CABLE FOR THE PATIENT CALL SWITCH HAS BURNED. THE MALFUNCTION OCCURRED DURING THE PROCEDURE. NO INJURY WAS REPORTED. THE SWITCH WAS STILL OPERABLE, THOUGH THE SITE WAS ASKED NOT TO USE IT UNTIL THEY ADDRESSED THE ISSUE. SINCE THE BURN WAS SIGNIFICANT ENOUGH TO MELT PLASTIC AND LEFT A MARK ON THE TABLE, THERE IS A POTENTIAL THE CABLE COULD HAVE BURNED THE PATIENT. DUE TO THE POTENTIAL RISK OF BURN TO PATIENT, FUJIFILM CORPORATION IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455628 ↗
• MalfunctionFeb 12, 2024Connection Problem; Connection Problem

  ON JANUARY 23RD 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT AFTER THE CUSTOMER RAN HER DAILY QA, SHE PUT HER FIRST PATIENT ON AND RAN THE SCANOGRAM AND GOT A WHITE LINE AND STARTED TO SMELL AN ELECTRICAL BURNING SMELL. THE CUSTOMER REBOOTED THE MACHINE AND TRIED TO SCAN AGAIN AND KEEPS GETTING ERRORS. THERE APPEAR TO BE AN ISSUE WITH THE GRADIENT CONTROL POWER AMPLIFIER (GCPA) UNIT. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685168 ↗
• MalfunctionJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 6TH 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT THE CUSTOMER REQUESTED A REVIEW ON AN ABDOMINAL CASE. IT WAS LATER REPORTED THAT A DR. STATES THAT A KNOWN ABDOMINAL LESION WAS APPARENTLY MISSED ON AN EXAM COMPLETED ON THE VELOCITY. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: Localized Skin Lesion

  MAUDE report 18503142 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EG-580UT. IT WAS REPORTED THAT THE CUSTOMER REQUESTED A REVIEW ON AN ABDOMINAL CASE. IT WAS LATER REPORTED THAT A DR. STATES THAT A KNOWN ABDOMINAL LESION WAS APPARENTLY MISSED ON AN EXAM COMPLETED ON THE VELOCITY. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Stomach Ulceration

  MAUDE report 18440617 ↗
• InjuryNov 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCTOBER 24TH 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING WITH SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT THE C-SPINE COIL WAS USED ON A PATIENT ON TUESDAY (B)(6) 2023, AND THE PATIENT HAS REDNESS IN THE CHEST AREA. IT WAS LATER REPORTED THAT THE PATIENT DID NOT SEEK MEDICAL TREATMENT. PATIENT LATER CONFIRMED THAT THE REDNESS WENT AWAY. THE COIL WAS NOT TOUCHING THE PATIENTS CHEST. THERE WAS NO DEATH ASSOCIATED WITH THE EVENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18193261 ↗
• InjuryNov 3, 2023Excessive Heating; Excessive Heating

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING WITH SYS/MR/OASIS OPEN+VERTEX II. IT WAS REPORTED THAT THE C-SPINE COIL WAS USED ON A PATIENT ON TUESDAY (B)(6) 2023, AND THE PATIENT HAS REDNESS IN THE CHEST AREA. IT WAS LATER REPORTED THAT THE PATIENT DID NOT SEEK MEDICAL TREATMENT. PATIENT LATER CONFIRMED THAT THE REDNESS WENT AWAY. THE COIL WAS NOT TOUCHING THE PATIENTS CHEST. THERE WAS NO DEATH ASSOCIATED WITH THE EVENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18065183 ↗
• MalfunctionJun 30, 2022Poor Quality Image; Poor Quality Image

  ON JUNE 17,2022 FUJIFILM HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING OASIS XP 1.2T OPEN MRI SYSTEM. THE CUSTOMER COMPLAINED ABOUT THE QUALITY OF BREAST IMAGING. THE PATIENT IS A KNOWN BREAST CANCER PATIENT AND IS ACTIVELY UNDERGOING TREATMENT. THE SITE REPORTED THE DISCREPANCY IN THE SIZE OF A LESION THAT WAS 75 MM ON A NON-FUJIFILM SYSTEM (SCAN WAS DONE ON (B)(6) 2022) VS ONLY 5 MM ON THE OASIS XP 1.2T OPEN MRI SYSTEM (SCAN WAS DONE ON (B)(6) 2022). THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880386 ↗
• MalfunctionJun 28, 2022Poor Quality Image; Poor Quality Image

  ON (B)(6) 2022 FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING OASIS XP 1.2T OPEN MRI SYSTEM. THE CUSTOMER COMPLAINED ABOUT THE QUALITY OF BREAST IMAGING. THE PATIENT IS A KNOWN BREAST CANCER PATIENT AND IS ACTIVELY UNDERGOING TREATMENT. THE SITE REPORTED THE DISCREPANCY IN THE SIZE OF A LESION THAT WAS 75 MM ON A NON-FUJIFILM SYSTEM (SCAN WAS DONE ON (B)(6) 2022) VS ONLY 5 MM ON THE OASIS XP 1.2T OPEN MRI SYSTEM (SCAN WAS DONE ON (B)(6) 2022). THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. AS SUCH, THIS IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841271 ↗
• MalfunctionMay 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON APRIL 28, 2022, FUJIFILM HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING THE OASIS XP 1.2T OPEN MRI SYSTEM. IT WAS REPORTED THAT A FEMALE PATIENT COMPLAINED OF RINGING IN THE LEFT EAR FOLLOWING A LOWER EXTREMITY SCAN. DURING THE SCAN, THE PATIENT WAS WEARING HEADPHONES AND LISTENING TO JAZZ MUSIC. THE TECHNICIAN CONFIRMED THAT THE PATIENT COULD HEAR THE MUSIC AT THE TIME OF THE SCAN. THE PATIENT STATED THAT SHE DID NOT NOTICE THE RINGING UNTIL SHE WAS HOME. NO HEARING LOSS WAS REPORTED AND NO FURTHER INFORMATION WAS PROVIDED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Tinnitus

  MAUDE report 14489913 ↗
• MalfunctionApr 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 03 MARCH 2022, FUJIFILM HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING OASIS XP 1.2T OPEN MRI SYSTEM. IT WAS REPORTED THAT A (B)(6) PATIENT COMPLAINED THAT THE SCANNER WAS REALLY LOUD AND HAD A SMELL TO IT. HE CALLED BACK THE DAY AFTER THE SCAN STATING THAT HIS EARS WERE STILL RINGING. THE PATIENT WAS CONCERNED IF THE MACHINE WAS WORKING PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Tinnitus

  MAUDE report 14084517 ↗
• InjuryMar 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022 FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING OASIS XP 1.2T OPEN MRI SYSTEM. IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT COMPLAINED THAT THE SCANNER WAS REALLY LOUD AND HAD A SMELL TO IT. HE CALLED BACK THE DAY AFTER THE SCAN STATING THAT HIS EARS WERE STILL RINGING. THE PATIENT WAS CONCERNED IF THE MACHINE WAS WORKING PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Tinnitus

  MAUDE report 13937953 ↗
• MalfunctionFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10 JANUARY 2022, FUJIFILM HEALTHCARE CORPORATION WAS INFORMED OF AN INCIDENT RELATED TO OASIS MRI SYSTEM. EVENT DESCRIPTION IS AS FOLLOWS: TECHNICIAN WAS TRYING TO TAKE A PATIENT OUT OF THE ROOM WITH A FERROUS WHEELCHAIR. AS THE TECHNICIAN BACKED THE WHEEL CHAIR INTO THE ROOM, WHEELCHAIR WAS PULLED IN BY THE MAGNET. SHE HAD THE BREATH KNOCKED OUT OF HER AND WAS PINNED BY HER HAND BUT WAS ABLE TO GET FREE. THE TECHNICIAN HAD TO GO TO URGENT CARE FOR MINOR INJURIES. SHE HAD A SPRAINED THUMB, BRUISED SHOULDER, AND TWISTED HER KNEE. PATIENT WAS NOT IN THE PATH OF THE CHAIR, THEREFORE THERE WERE NO INJURIES TO THE PATIENT. THERE IS NO PATIENT INJURY OR DEATH ASSOCIATED WITH EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 13423231 ↗
• InjuryFeb 9, 2018Device Issue; Adverse Event Without Identified Device or Use Problem; Device Issue; Adverse Event Without Identified Device or Use Problem

  A SHOULDER PATIENT SCANNED ON 1/10 COMPLAINED OF A BURN 2 DAYS LATER. THE PATIENT HAS REDNESS AROUND THE SHOULDER WHERE THE COIL WAS PLACED. THE PATIENT WAS IN A GOWN AND THERE WAS NO DIRECT CONTACT WITH THE COIL TO THE PATIENT. THE PATIENT DID NOT COMPLAIN OF A BURNING SENSATION AT THE TIME OF THE EXAM OR AFTER THE EXAM, ONLY 2 DAYS AFTER THE FACT. THE TECH DID NOT NOTICE ANY HEATING ON THE COIL AT THE TIME OF THE EXAM OR ON ANY OTHER EXAM. ON (B)(6), HITACHI WAS NOTIFIED THAT THE PATIENT IS BEING TREATED BY A PHYSICIAN WITH A BURN OINTMENT IN THE SHOULDER AREA, BUT IT IS UNKNOWN IF THE PATIENT HAD BLISTERING OR JUST REDNESS. SITE HAS NOT SEEN THE PATIENT TO CONFIRM INJURY.

  Patient problems: Burn(s); Injury; Partial thickness (Second Degree) Burn; Patient Problem/Medical Problem

  MAUDE report 7259027 ↗
• InjuryJan 9, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Device Issue; Human Factors Issue; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Issue; Human Factors Issue

  A PATIENT RECEIVED A SHOULDER EXAM ON THE HITACHI OASIS MRI SYSTEM ON (B)(6) 2017. THE PATIENT CALLED SITE AND LEFT A VOICEMAIL 5 DAYS AFTER EXAM TO REPORT THAT HE HAD REDNESS ON HIS BELLY WHICH TURNED INTO BLISTERS. THE PATIENT WAS SCHEDULED TO SEE HIS PRIMARY CARE DOCTOR ON (B)(6) 2017. SITE HAS NOT SEEN THE PATIENT TO CONFIRM INJURY.

  Patient problems: Burn(s); Injury; Partial thickness (Second Degree) Burn; Patient Problem/Medical Problem

  MAUDE report 7174826 ↗
• InjuryJun 14, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Device Issue; Human Factors Issue; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Issue; Human Factors Issue

  THE TECHNOLOGIST WAS SETTING UP A PATIENT EXAM ON THE HITACHI OASIS MRI SYSTEM ON (B)(6) 2017. DURING PATIENT SETUP, THE TECHNOLOGIST WENT AROUND THE TABLE END TO SPEAK WITH THE PATIENT. THE TABLE WAS SET UP FOR A LUMBAR STUDY, AND HIS FINGER WAS CUT BY THE METAL TAPE THAT RUNS DOWN THE CENTER OF THE TABLE. THE TABLE WASN'T IN MOTION, HE JUST TOUCHED THE METAL TAPE WITHOUT REALIZING TAPE IS SHARP. INITIALLY HE DIDN'T FEEL ANYTHING, UNTIL HE NOTICED THE BLOOD. THE TECHNOLOGIST CONFIRMED ON 6/12/2017 THAT HE WENT TO URGENT CARE AND GOT 4 STITCHES AND WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: No Patient Involvement; Patient Problem/Medical Problem

  MAUDE report 6641531 ↗