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GETINGE CM320-SERIES (REF CM320WWWD)Recalls & reported problems

Getinge Disinfection AB · CM320-4 CHAMBER WWWD. Washer disinfector with four chambers; Three washer chambers followed by a dryer chamber. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340153700215), received between Jul 26, 2017 and Jul 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Falling” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Dec 21, 2020Terminated

    The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.

    Z-1124-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

  • Component Falling1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 26, 2017Component Falling; Component Falling

    ON (B)(4) GETINGE BECAME AWARE OF AN INCIDENT CAUSED BY ONE OF THE MEDICAL DEVICES MANUFACTURED BY GETINGE. FROM INFORMATION PROVIDED BY THE CUSTOMER AFTER THE WASHING PROCESS THE WASH CART FROM CM320 WASHER DISINFECTOR HAD BEEN TRANSFERRED ON THE UNLOADING CONVEYOR AND MOVED TO THE CLEAN SIDE. THE WASH CART DURING THE PROPER OPERATION SHOULD STOPPED WHEN REACHED END OF THE UNLOADER. HOWEVER IN THE CASE REPORTED BY THE CUSTOMER THE WASH CART OVERTURNED AND FELL DOWN TO THE GROUND. SERVICE TECHNICIAN WHO ARRIVED ON SITE REPORTED THAT STOP PIN WAS BROKEN. AS A RESULT OF THE EVENT NO INJURY HAS BEEN REPORTED. HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

    MAUDE report 6743450 ↗

Other Disinfector, Medical Devices devices

All Disinfector, Medical Devices devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.