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GETINGE WD 15 CLARO GE15Recalls & reported problems

Getinge Disinfection AB · GETINGE WD 15 CLARO, WASHER DISINFECTOR · Class 2

Data updated Oct 16, 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 07340153700239), received between Sep 19, 2017 and Feb 25, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling 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.

Most reported problems

Device problems

  • Device Handling Problem1
  • No Apparent Adverse Event1
  • Overheating of Device1
  • Sharp Edges1

Patient problems

  • Injury1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 25, 2021No Apparent Adverse Event; Device Handling Problem; Sharp Edges; No Apparent Adverse Event; Device Handling Problem; Sharp Edges

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Patient problems: Injury

    MAUDE report 11378826 ↗
  • MalfunctionSep 19, 2017Overheating of Device; Overheating of Device

    ON 30TH AUGUST 2017 GETINGE BECAME AWARE OF AN INCIDENT WHICH WAS A RESULT OF OVERHEATED CLARO DEVICE. AS IT WAS STATED OVERHEATED ELEMENTS OF WASHER DISINFECTOR CAUSED SMOKE EMISSION WHICH ACTIVATED FIRE ALARM. ALARM ACTIVATION RESULTED IN DELAYS IN SURGERIES PLANNED AT CUSTOMER SITE. NO INJURY HAS BEEN REPORTED DUE TO DESCRIBED SITUATION. HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 6875170 ↗

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Sources and updates

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