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ULTRASONIC PROBE UM-DP20-25R (UDI 04953170143663)Recalls & reported problems

Olympus Medical Systems Corp. · "N1027530 OLA UM-DP20-25R DUAL PLANE RECO" · Class 2

All models of ULTRASONIC PROBE (17)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170143663), received between Apr 18, 2024 and Mar 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Material Deformation1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 17, 2026Material Deformation; Material Twisted/Bent

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24616886 ↗
  • MalfunctionJul 16, 2024Break; Break

    IT WAS OBSERVED, THAT DURING, THE DEVICE EVALUATION. THE SUBJECT DEVICE EXHIBITED SCRATCHES ON THE PROBE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19757467 ↗
  • MalfunctionApr 18, 2024Break; Break

    IT WAS REPORTED, THE ULTRASONIC PROBE HAD A DISTAL END CORE OF PROBE CANNOT BE RESET. IT COULD NOT RETURN TO ITS ORIGINAL POSITION AND NO IMAGE LOSS OCCURRED. THE ISSUE OCCURRED DURING CLEANING AND DISINFECTION. THE PROCEDURE WAS A DIAGNOSTIC ULTRASOUND EXAMINATION. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19135712 ↗

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Sources and updates

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