H60 V2.00 Diagnostic Ultrasound System USS-H60NF4L/USRecalls & reported problems
Samsung Medison CO., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08806167752965), received between Feb 16, 2017 and Feb 16, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Software Programming Calculations” (2 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
Device problems
- Incorrect Software Programming Calculations2
Patient problems
- Pregnancy2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2017Incorrect Software Programming Calculations; Incorrect Software Programming Calculations
THE EDD (AUA) VALUE WAS NORMALLY DISPLAYED ON THE DAY OF MEASUREMENTS, BUT IN THE EXAM REVIEW AFTER THE DAY OF MEASUREMENTS, THE EXISTING EDD (AUA) VALUE WAS CHANGED. THESE INTERMITTENT CHANGES IN EDD MAY INDICATE A POTENTIAL FETAL GROWTH ISSUE.
Patient problems: Pregnancy
MAUDE report 6337372 ↗MalfunctionFeb 16, 2017Incorrect Software Programming Calculations; Incorrect Software Programming Calculations
THE EDD (AUA) VALUE WAS NORMALLY DISPLAYED ON THE DAY OF MEASUREMENTS, BUT IN THE EXAM REVIEW AFTER THE DAY OF MEASUREMENTS, THE EXISTING EDD (AUA) VALUE WAS CHANGED. THESE INTERMITTENT CHANGES IN EDD MAY INDICATE A POTENTIAL FETAL GROWTH ISSUE.
Patient problems: Pregnancy
MAUDE report 6337362 ↗
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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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