GETINGE CM320-SERIES (REF CM320WUWD)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340153700192), received between May 26, 2025 and Apr 20, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

2 FDA recall records name this device's identifier, 1 still open.

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. Apr 13, 2022Open, Classified

   Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

   Z-1249-2022 · Root cause: Process control · FDA record ↗

2. 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

Recent adverse event reports

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

• MalfunctionApr 20, 2026Detachment of Device or Device Component

  A COMPLAINT WAS RECEIVED BY GETINGE REGARDING A CM320 WASHER-DISINFECTOR. DURING OPERATION ON THE UNIT, AN INCIDENT OCCURRED IN WHICH THE PANEL THAT SITS ABOVE THE SCREEN/ENTRY CHAMBER 1 DOOR (SOILED SIDE) DETACHED FROM THE UNIT AND FELL ONTO A STAFF MEMBER¿S ARM. INITIAL INSPECTION REVEALED ONE OF THE FOUR HOOKS THAT SECURES THE PANEL TO THE UNIT SNAPPED OFF AND APPEARS BENT. THE STAFF MEMBER WAS ABLE TO COMPLETE THEIR SHIFT BUT SUBSEQUENTLY REPORTED THE INJURY (GRAZE AND/OR BRUISING AND SWELLING), AND CALLED IN SICK FOR THEIR NEXT DAY SCHEDULED SHIFT.

  Patient problems: Abrasion; Angioedema

  MAUDE report 24921725 ↗
• MalfunctionDec 11, 2025Fire; Fire; Overheating of Device

  GETINGE RECEIVED INFORMATION THAT THE HEATING WIRE IN THE ULTRASONIC CAVITY FOR THIS DEVICE TURNED RED DURING OPERATION. UPON INSPECTION, IT WAS FOUND THAT THE SHORTING WIRE OF THE HEATING ELEMENT HAD BURNT OUT AND REQUIRED REPLACEMENT. IT WAS REPORTED THAT THE FUSE WAS NOT IMPACTED. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776775 ↗
• MalfunctionMay 26, 2025Fire; Fire

  GETINGE BECAME AWARE OF AN ISSUE INVOLVING THE CM320-SERIES WASHER DISINFECTOR. INITIAL INFORMATION INDICATED THAT A FIRE OCCURRED UPON POWERING ON THE EQUIPMENT IN THE MORNING. ACCORDING TO THE INFORMATION PROVIDED BY THE SALES AND SERVICE UNITS, THE CAUSE OF THE INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THE TIME. THE FIRE APPEARS TO HAVE ORIGINATED IN THE AREA BETWEEN THE ULTRASOUND CHAMBER (SECOND CHAMBER) AND THE CLEANING AND DISINFECTION CHAMBER (THIRD CHAMBER), WITH VISIBLE DAMAGE OBSERVED BENEATH THE THIRD CHAMBER. THE FACILITY SPRINKLER SYSTEM WAS ACTIVATED AND FUNCTIONED AS INTENDED, WHICH SUCCESSFULLY CONTAINED THE FIRE. AT THE TIME OF THAT INITIAL INFORMATION RECEIVED THE CAUSE OF THE FIRE WAS NOT KNOWN TO BE DEVICE RELATED. AN INVESTIGATION WAS INITIATED, AND THE RETURN OF RELEVANT PARTS WAS REQUESTED TO SUPPORT CAUSE ANALYSIS. AT THE TIME OF THIS REPORT, NO SERIOUS INJURIES HAVE BEEN REPORTED IN CONNECTION WITH THE INCIDENT, HOWEVER WE HAVE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL OF HARM IF THE ISSUE WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083718 ↗