FibroScan FibroScan 530 CompactRecalls & reported problems
Echosens · Class 2
Data updated Oct 16, 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 03662264001185), received between Feb 9, 2026 and Feb 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Battery Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem1
- Flare or Flash1
- Overheating of Device1
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.
MalfunctionFeb 9, 2026Overheating of Device; Battery Problem; Flare or Flash
BETWEEN TWO EXAMINATIONS. STAFF MEMBERS REPORTED SPARKS AND A BURNING SMELL. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE ROOM AND TAKEN TOWARD AN OPEN AREA. WHILE IT WAS BEING MOVED, THE MACHINE CAUGHT FIRE. THE FIRE SELF-EXTINGUISHED WITH IN A FEW SECONDS. NO HARM OCCURED TO ANY PERSON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291612 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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