HITACHI PROSOUND F75Recalls & reported problems
Hitachi, Ltd. · Diagnostic Ultrasound System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04562122956185), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Image Display Error/Artifact; Output Problem; Image Display Error/Artifact; Output Problem
ON MAY 23RD 2024, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING PROSOUND F75. IT WAS REPORTED THAT THE ULTRASOUND IMAGE FLIPPED BY ITSELF DURING BIOPSY. PHYSICIAN CANCELED THE PATIENT BIOPSY AND CUSTOMER ARE UPSET AND THEY DON'T TRUST THEIR ULTRASOUND UNIT. DR. COMPLAINED THAT THEY ARE WAITING 2 WEEKS BEFORE GETTING THEIR EQUIPMENT REPAIR. THE PROCEDURE WAS NOT COMPLETED. PHYSICAN CANCELED AND POSTPONED THE PATIENT DIAGNOSIS FOR PANCREAS CANCER. INITIALLY, BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURER, FUJIFILM CORPORATION, DETERMINED THAT MANUFACTURER MDR IS NOT NECESSARY. HOWEVER, AFTER NEW INFORMATION BECAME AVAILABLE FROM THE SITE (07/02/2024), FUJIFILM CORPORATION IS FURTHER INVESTIGATING THE EVENT. THIS MANUFACTURER'S MDR IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19840477 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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