HITACHI NoblusRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04580292771704), received between Oct 18, 2021 and Mar 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (2 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 16, 2026.

Recalls naming this device

1. Apr 11, 2024Open, Classified

   AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).

   Z-1884-2024 · Root cause: Device Design · 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.

• InjuryMar 8, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ON (B)(6) 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI HEALTHCARE AMERICAS CORPORATION) RECEIVED A COMPLAINT REGARDING NOBLUS ULTRASOUND. THE SITE REPORTED THAT A PATIENT WAS UNDER ANESTHESIA AND UNDERGOING A PROSTATE CRYO PROCEDURE WITH A BI-PLACE C41L47RP PROBE. SITE TECHNICIAN TURNED ON THE NOBLUS SYSTEM AND ATTACHED THE PROBE. THE SYSTEM WOULD NOT BOOT UP READY AND REPORTED AN ERROR ASKING TO "PLEASE WAIT UNTIL THE ERROR LOG IS COMPLETE." A PROMPT WOULD POP UP WITH THE OPTION TO HIT "OK", AND WHEN HE DID, THE SYSTEM WOULD SHUT DOWN. TECH ATTEMPTED TO REBOOT SEVERAL TIMES, BOTH WITH AND WITHOUT A PROBE ATTACHED, AND EVEN TRIED TO REPLACE THE BATTERY. ERROR PERSISTED. THE PROCEDURE WAS RESCHEDULED. THERE WERE NO SIDE EFFECTS FROM THE ANESTHESIA AND THE PATIENT WAS CLEARED TO GO HOME. THERE WAS NO INJURY/HARM OR DEATH REPORTED WITH THIS EVENT. 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 13686566 ↗
• InjuryOct 18, 2021Computer Software Problem; Application Program Problem; Unintended Application Program Shut Down; Computer Software Problem; Application Program Problem; Unintended Application Program Shut Down

  ON SEPTEMBER 20 2021, FUJIFILM HEALTHCARE AMERICAS RECEIVED A REPORT OF AN ABORTED PROCEDURE WHILE PATIENT WAS UNDER ANESTHESIA. THE SITE WAS USING THE NOBLUS ULTRASOUND UN0581.

  Patient problems: Insufficient Information

  MAUDE report 12647907 ↗