GETINGE CM320-SERIESRecalls & reported problems across all models

We found 6 models of GETINGE CM320-SERIES by Getinge Disinfection AB in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and Apr 20, 2026 — classified as 5 malfunctions.

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

3 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GETINGE CM320-SERIES recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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-1248-2022 · Root cause: Process control · Recall details · FDA record ↗

3. 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 · names 6 of these models · Recall details · FDA record ↗

Most reported GETINGE CM320-SERIES problems

GETINGE CM320-SERIES models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  2 recalls3 reports
• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  2 recalls1 report
• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  1 recall1 report
• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  1 recall0 reports
• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  1 recall0 reports
• GETINGE CM320-SERIES

  Disinfector, Medical Devices
  1 recall0 reports

Recent GETINGE CM320-SERIES adverse event reports

The 5 most recent reports across all models, 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 ↗
• MalfunctionNov 3, 2023Device Fell; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18063075 ↗
• 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 Getinge Disinfection AB products

• GETINGE 88-SERIES2 models · 6 reports · 3 recalls
• Getinge Aquadis 562 models · 13 reports · 2 recalls
• GETINGE 46-SERIES3 models · 4 reports · 2 recalls
• GETINGE 86-SERIES5 models · 39 reports · 1 recall
• GETINGE 9100-SERIES6 models · 17 reports · 1 recall