NA WD 290 IQRecalls & reported problems
Belimed AG · 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 07640141626177), received between Jun 2, 2023 and Jan 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
- Misassembled During Installation1
Patient problems
- Insufficient Information1
- Neck Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Misassembled During Installation
WHILE A HOSPITAL EMPLOYEE WAS TRYING TO READ JUST AN INCORRECTLY POSITIONED, LOADED RACK THAT HAD ALREADY BEEN PLACED INSIDE THE WASHER, THE FRONT TOP PANEL OF THE WASHER CAME LOOSE AND FELL ONTO THE EMPLOYEE'S NECK. HE WAS INJURED BUT DID NOT MISS ANY WORKDAYS AND WAS ABLE TO RESUME WORK SHORTLY AFTER THE INCIDENT.
Patient problems: Insufficient Information; Neck Pain
MAUDE report 24159576 ↗MalfunctionJun 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE PLASTIC DRAIN OF THE WASHER WAS DAMAGED BY THE HOSE CLAMP, PRODUCING A DEEP CUT THAT STARTED TO LEAK AND FLOODED THE FLOOR OF THE CSSD AROUND THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050158 ↗
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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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