HITACHI Aloka Arietta 850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04562122958974), received between Apr 20, 2022 and May 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 14, 2021Class IIOpen, Classified

   Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

   Z-0190-2022 · Root cause: Software design · Recall details · FDA record ↗

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.

• 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 BLACKED OUT DURING A PROCEDURE. THE INCIDENT RESULTED IN A MINOR DELAY, HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE WITHOUT HARM TO THE PATIENT. 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 14287387 ↗
• 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 SCREEN BLACKED OUT DURING THE PROCEDURE. 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 14220628 ↗
• MalfunctionApr 20, 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 DURING THE EXAM, THE ARIETTA 850 SCREEN WENT BLANK WITH NOTHING ON THE TOUCH SCREEN AND THE OPERATION PANEL LIGHTS STARTED TO FLASH LIKE IT WAS REBOOTING. THE PATIENT WAS UNDER ANESTHESIA AT THIS TIME. THE SITE CHANGED TO THE OTHER ARIETTA 850 AND WERE ABLE TO COMPLETE THE PROCEDURE. THERE WAS 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 14163658 ↗