RS80A Diagnostic Ultrasound System USS-RS8AF4U/USRecalls & reported problems
Samsung Medison CO., Ltd. · 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 08806167760045), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (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.
Most reported problems
Device problems
- Application Program Problem: Parameter Calculation Error1
Patient problems
- Missing Value Reason1
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2017Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error
SOFTWARE ISSUE DETECTED BY APPLICATIONS SPECIALIST ON A RS80A PRESTIGE SYSTEM RUNNING SOFTWARE VERSION 3.00.03. WHEN THE BLOOD FLOW VELOCITY OF REVERSE DIRECTION IS MEASURED WITH THE SETTING VALUE CHANGED FROM "PROXIMAL" TO "HIGHEST" IN THE ICA / CCA RATIO OPTION AS THE DEFAULT VALUE, NON-HIGHEST VALUE IS DISPLAYED AS "HIGHEST PSV/EDV". THE ISSUE PERTAINS TO CAROTID EXAMS WHERE THE RS80A SOFTWARE IS NOT DISPLAYING THE ABSOLUTE VALUE.
Patient problems: Missing Value Reason; No Information
MAUDE report 6354949 ↗
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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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