ALOKA ARIETTA 850Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04573596214046), received between Apr 26, 2022 and Sep 18, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Application Program Freezes or Fails to Launch

  During RFA treatment, as the tip of the needle on the puncture probe was brought close to the liver mass, the device froze and became inoperable, making it impossible to confirm the position of the puncture needle.The physician therefore forcibly shut down and restarted the device, then continued and completed the procedure.There were no health effects on the patients.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814246 ↗
• MalfunctionAug 9, 2022No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  ON JULY 14, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE IMAGE WAS LOST DURING A STUDY, AND THE SYSTEM POWER CYCLED ITSELF ON ITS OWN. THE STUDY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR PATIENT INJURY AFTER THE SYSTEM REBOOTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192183 ↗
• MalfunctionAug 2, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE IMAGE WAS LOST DURING A BIOPSY PROCEDURE THE SYSTEM WAS REBOOTED AND THE STUDY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR PATIENT INJURY. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149782 ↗
• MalfunctionJun 17, 2022No Display/Image; No Display/Image

  ON JUNE 13, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE IMAGE DOES NOT APPEAR UNTIL THE SYSTEM IS REBOOTED. THE ERROR OCCURRED PRIOR TO BEGINNING A PROCEDURE AND CAUSED A SLIGHT DELAY THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A SYSTEM REBOOT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733177 ↗
• MalfunctionJun 13, 2022No Display/Image; No Display/Image

  ON JUNE 03, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. IT WAS REPORTED THAT THE SOFTWARE FREEZES DURING CASES AND THIS ISSUE OCCURRED MULTIPLE TIMES. THE IMAGE DISAPPEARS FROM THE SCREEN AND THE TECHNICIAN MUST REBOOT THE SYSTEM TO CONTINUE THE PROCEDURE. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675738 ↗
• MalfunctionMay 31, 2022No Display/Image; No Display/Image

  ON MAY 20, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE IMAGE OUTPUT IS FREQUENTLY BLACK AND THE SYSTEM MUST BE REBOOTED FOR THE IMAGES TO REAPPEAR. THE STUDIES ARE ABLE TO CONTINUE FOLLOWING A SYSTEM REBOOT. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14551621 ↗
• MalfunctionMay 31, 2022No Display/Image; No Display/Image

  ON MAY 17, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SYSTEM SHUTS DOWN IN THE MIDDLE OF CASES. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14551567 ↗
• MalfunctionMay 20, 2022No Display/Image; No Display/Image

  ON MAY 11, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SCREEN BLACKS OUT, AND THE SYSTEM FREEZES AND BECOMES UNRESPONSIVE TO KEYBOARD COMMANDS. WHEN A NEW PATIENT OR PROBE IS SELECTED THE ONSCREEN IMAGES WILL REAPPEAR. THE PROCEDURES WERE THEN COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454327 ↗
• MalfunctionMay 5, 2022No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SCREEN WENT BLACK AND SUBSEQUENTLY SHUT DOWN ON ITS OWN. THERE WAS NO ERROR MESSAGE DISPLAYED. THEY WERE ABLE TO REBOOT SUCCESSFULLY BUT THEN THE SCREEN WENT BLACK AGAIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ULTRASOUND SYSTEM. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287922 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT IMAGES ARE INTERMITTENTLY NOT BEING DISPLAYED WHEN THE PROBE IS PLUGGED INTO THE SYSTEM. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287397 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON APRIL 07, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SYSTEM'S NEW PATIENT SETTING IS NOT WORKING PROPERLY AND RESULTING IN DISAPPEARING IMAGES. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287296 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON APRIL 15, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT DURING A BIOPSY PROCEDURE THE MONITOR WENT BLANK AND THE CONSOLE GREYED OUT. THE PROBE BUTTON NEEDED TO BE REACTIVATED TO BRING THE IMAGE BACK UP. ALTHOUGH THE INCIDENT CAUSED A DELAY IN THE PROCEDURE, THE BIOPSY WAS SUCCESSFULLY RETRIEVED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287278 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON FEBRUARY 08, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE MACHINE FREEZES UP INTERMITTENTLY AND MAIN SCREEN GOES BLACK WITH JUST A CURSOR. ONCE THEY REBOOT IT IS FINE FOR REST OF THE DAY. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286427 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON MARCH 04, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT WHEN THEY CONNECT THE OLYMPUS BF-UC190F ULTRASOUND SCOPE, THE SCREEN GOES BLANK WHEN NOT IN FREEZE MODE. THEY CAN SEE THE PROBE BUT THEN IT GOES TO A BLACK SCREEN WITH NO IMAGE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286413 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THEY SUDDENLY LOST ABILITY TO USE THE PANEL BUTTONS. THE SCREEN WAS GRAYED OUT, EXCEPT FOR THE PROBE SELECT AND THE PATIENT DATA BUTTONS. THEY RESELECTED THE PROBE AND WERE ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286404 ↗
• MalfunctionMay 5, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SCREEN GOES BLACK IN THE MIDDLE OF PROCEDURE. THEY HAD TO RESELECT THE PROBE AND WERE ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH THE SAME DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT REPORTED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS INITIALLY IDENTIFIED AS A NON-REPORTABLE EVENT. DURING A RETROSPECTIVE REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT SHOULD BE REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286297 ↗
• InjuryApr 29, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT DURING THE THERAPEUTIC CHOLEDOCHODUODENOSTOMY, THE SCREEN BLACKED OUT DURING THE DEPLOYMENT OF A BOSTON SCIENTIFIC AXIOS STENT AND A PATIENT SUSTAINED A BILIARY PERFORATION. A SURGERY WAS REQUIRED TO TREAT THE PERFORATION. THE PATIENT WAS STABLE POST PROCEDURE. THE EVENT DATE IS UNKNOWN. THERE IS NO DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Perforation

  MAUDE report 14254848 ↗
• MalfunctionApr 27, 2022No Display/Image; No Display/Image

  ON MARCH 31, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SYSTEM TIMED OUT DURING A PROCEDURE WHILE THE PHYSICIAN WAS SAMPLING A NODE. THEY LOST THE IMAGE AND HAD TO SELECT THE PROBE BUTTON TO GET IT REACTIVATED. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220736 ↗
• MalfunctionApr 27, 2022No Display/Image; No Display/Image

  ON MARCH 30, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE ARIETTA 850 PANEL WENT BLANK EXCEPT THE PATIENT ID AND PROBE BUTTON, THEY WERE STILL LIT UP BLUE, BUT THE IMAGE WAS LOST. THE STAFF WAS ABLE TO SELECT PROBE AND PRESET. THE ISSUE OCCURRED TWICE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME SCOPE, CABLES AND TOWER SET-UP. THERE WAS NO PATIENT INJURY OR HARM REPORTED WITH THIS EVENT. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220384 ↗
• InjuryApr 26, 2022No Display/Image; No Display/Image

  ON MARCH 31, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT DURING THE THERAPEUTIC CHOLEDOCHODUODENOSTOMY, THE SCREEN BLACKED OUT DURING THE DEPLOYMENT OF A BOSTON SCIENTIFIC AXIOS STENT AND A PATIENT SUSTAINED A BILIARY PERFORATION. A SURGERY WAS REQUIRED TO TREAT THE PERFORATION. THE PATIENT WAS STABLE POST PROCEDURE. THE EVENT DATE IS UNKNOWN. THERE WAS NO DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Perforation

  MAUDE report 14215234 ↗
• MalfunctionApr 26, 2022No Display/Image; No Display/Image

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A COMPLAINT REGARDING THE ARIETTA 850 ULTRASOUND SYSTEM. THE SITE REPORTED THAT THE SYSTEM RECOGNIZES SCOPE BUT OCCASIONALLY THERE IS NO IMAGE. THE TEXT APPEARS AROUND ULTRASOUND IMAGE, BUT IMAGE IS BLACK. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213065 ↗