Bladder Scanner MD-6000Recalls & reported problems
Meda Co., Ltd · MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to measure the volume of bladder filled with urine. · Class 2
Data updated Oct 13, 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 06948941160008), received between Jun 24, 2022 and Sep 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Output 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem1
Patient problems
- Insufficient Information1
- Urinary Retention1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024
PATIENT CAME INTO THE DEPARTMENT COMPLAINING OF URINARY RETENTION. BLADDER SCAN WAS ORDERED AND PERFORMED HOWEVER THE BLADDER SCANNER WAS NOT READING ACCURATE RESULTS.
Patient problems: Urinary Retention
MAUDE report 20256029 ↗MalfunctionJun 24, 2022Output Problem
BLADDER SCANNER WAS USED ON PATIENT TO ASSESS FOR RETENTION. BLADDER SCANNER SHOWED VOLUMES BETWEEN 600-800MLS. FOLEY WAS TO BE PLACED FOR PATIENT. WHEN FOLEY WAS PLACED THERE WAS NO OUTPUT. 3 SEPARATE NURSES ATTEMPTED TO INSERT FOLEY IN ORDER TO GET URINE OUTPUT. NURSE WENT TO CROSS REFERENCE WITH ANOTHER BLADDER SCANNER ON UNIT BEFORE UROLOGY NEEDED TO BE CONSULTED. THE SECOND BLADDER SCANNER SHOWED VOLUME OF 153.
Patient problems: Insufficient Information
MAUDE report 14799259 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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