GETINGE 86-SERIESRecalls & reported problems across all models

We found 5 models of GETINGE 86-SERIES by Getinge Disinfection AB in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2017 and Apr 13, 2026 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Device Fell” (13 reports).

1 FDA recall record name at least one of these models by its device 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. 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 86-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. Mar 2, 2018Terminated

   There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

   Z-1379-2018 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗

Most reported GETINGE 86-SERIES problems

GETINGE 86-SERIES models

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

• GETINGE 86-SERIES S-8668

  Disinfector, Medical Devices
  1 recall37 reports
• GETINGE 86-SERIES S-8666

  Disinfector, Medical Devices
  1 recall1 report
• GETINGE 86-SERIES S-8666

  Disinfector, Medical Devices
  1 recall0 reports
• GETINGE 86-SERIES S-8668

  Disinfector, Medical Devices
  1 recall0 reports
• Getinge 86-Series S-8668T

  Disinfector, Medical Devices
  1 report

Recent GETINGE 86-SERIES adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Electrical /Electronic Property Problem

  A CUSTOMER REPORTED AN INCIDENT IN WHICH A STAFF MEMBER ALLEGEDLY EXPERIENCED AN ELECTRIC SHOCK WHILE ATTEMPTING TO REPLACE SOAP IN THE UNIT. ACCORDING TO THE ALLEGATION, THE INDIVIDUAL LOST CONSCIOUSNESS AND WAS SUBSEQUENTLY TRANSPORTED TO THE EMERGENCY ROOM. ADDITIONAL INFORMATION OBTAINED FROM FOLLOW-UP COMMUNICATION INDICATES THAT THE STAFF MEMBER MAY HAVE BEEN ATTEMPTING TO ADDRESS A DRAIN-RELATED ISSUE AT THE TIME OF THE INCIDENT. THE INDIVIDUAL WAS HOSPITALIZED FOR APPROXIMATELY THREE DAYS AND REMAINED UNDER MEDICAL SUPERVISION, ALTHOUGH SPECIFIC DIAGNOSTIC PROCEDURES AND FINDINGS WERE NOT PROVIDED. NO MEDICAL LEAVE WAS REPORTED FOLLOWING DISCHARGE. A SERVICE TECHNICIAN WAS DISPATCHED TO THE SITE TO INVESTIGATE THE REPORTED EVENT. UPON ARRIVAL, THE TECHNICIAN OBSERVED THAT THE SERVICE PANEL ADJACENT TO THE WASHER HAD BEEN REMOVED. A COMPREHENSIVE INSPECTION OF THE EQUIPMENT WAS CONDUCTED, INCLUDING VERIFICATION OF CIRCUIT BREAKERS (NO TRIPPED BREAKERS FOUND), INSPECTION FOR SIGNS OF OVERHEATING OR ELECTRICAL DAMAGE (NO ABNORMAL ODORS OR BURNED COMPONENTS DETECTED), AND ASSESSMENT OF WIRING AND CONNECTIONS, INCLUDING INCOMING THREE-PHASE POWER AND GROUNDING. ALL CONNECTIONS W

  Patient problems: Electric Shock

  MAUDE report 24857978 ↗
• MalfunctionApr 17, 2024Use of Device Problem; Device Fell; Use of Device Problem; Device Fell

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

  Patient problems: Limb Pain; Pain

  MAUDE report 19123424 ↗
• MalfunctionMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. IT WAS ALLEGED THAT THERE WERE LOADING ISSUES. THE GETINGE SERVICE TECHNICIAN VISITED THE SITE AND FOUND THAT CART HAD FALLEN OF THE LOADING TROLLEY TO THE GROUND. IT WAS CAUSED BY A MECHANICAL FAILURE ON THE LOADING TROLLEY. THE TROLLEY WAS REPAIRED AND THE UNIT WAS HANDED BACK TO THE CUSTOMER IN A FULLY WORKING CONDITION. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS CARTS FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957584 ↗
• MalfunctionMar 12, 2024Device Fell; Device Fell

  ON FEBRUARY 29, 2024 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE AUTOMATION LOADING SYSTEM WITH THE MODEL NAME: AGS 2.0. THE GETINGE AGS 2.0 IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS USED WITH THE FOUR MEDICAL DEVICES - 86-SERIES WASHER DISINFECTORS WITH THE MODEL NAME: 8668. AS IT WAS STATED, THE RACK ALMOST FELL ON THE FLOOR. GATHERED INFORMATION ALLOWED US TO ESTABLISH THAT DEVICE WAS RESTARTED AND IT WAS RETURNED TO THE SERVICE IN FULL WORKING CONDITION. THERE WAS NO ALLEGATION OF INJURY HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A RACK FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884408 ↗
• MalfunctionMar 12, 2024Device Fell; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884319 ↗
• MalfunctionMar 12, 2024Device Fell; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884317 ↗
• MalfunctionMar 12, 2024Device Fell; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884316 ↗
• MalfunctionFeb 9, 2024Device Fell; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674401 ↗
• MalfunctionFeb 8, 2024Device Fell; Device Fell

  ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH A LOADING TROLLEY WITH A SERIAL NUMBER: (B)(6) , WHICH WAS USED WITH ONE OF THREE 86-SERIES WASHER-DISINFECTORS WITH SERIAL NUMBERS:(B)(6) . A CUSTOMER ALLEGATION WAS THAT THE TROLLEY IS MISSING STOPPER. GETINGE TECHNICIAN VISITED SITE AND WAS INFORMED THAT THE TROLLEY HAD BEEN PUSHED ONTO THE LOADER INCORRECTLY AND HAD FALLEN ON THE FLOOR SNAPPING OF ONE OF THE ARMS ON THE CARRIER. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY ADVERSE CONSEQUENCES OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE TROLLEY FALLING TO THE GROUND MAY RESULT IN A SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668301 ↗
• MalfunctionFeb 8, 2024Device Fell; Device Fell

  ON JANUARY 16, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH A LOADING TROLLEY WITH A SERIAL NUMBER: (B)(6), WHICH WAS USED WITH ONE OF THREE 86-SERIES WASHER-DISINFECTORS WITH SERIAL NUMBERS: (B)(6). A CUSTOMER ALLEGATION WAS THAT THE TROLLEY IS MISSING STOPPER. GETINGE TECHNICIAN VISITED SITE AND WAS INFORMED THAT THE TROLLEY HAD BEEN PUSHED ONTO THE LOADER INCORRECTLY AND HAD FALLEN ON THE FLOOR SNAPPING OF ONE OF THE ARMS ON THE CARRIER. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY ADVERSE CONSEQUENCES OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE TROLLEY FALLING TO THE GROUND MAY RESULT IN A SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666310 ↗
• MalfunctionOct 27, 2023Corroded; Device Fell; Corroded; Device Fell

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020028 ↗
• MalfunctionSep 15, 2023Device Fell; Device Fell

  ON SEPTEMBER 13, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. AS IT WAS STATED, THE CART FELL TO THE GROUND. THERE WAS NO ALLEGATION OF INJURY HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS A CART FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION REOCCURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17753907 ↗
• MalfunctionJul 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 7TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE 86-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 8668. AS IT WAS STATED, CARTS FELL OFF THE TROLLEY. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS CARTS FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369417 ↗
• MalfunctionMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627131 ↗
• MalfunctionMar 1, 2023Installation-Related Problem; Installation-Related Problem

  ON 17TH FEBRUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTOR WITH THE MODEL NAME 8668. AS IT WAS STATED, THE INCORRECT DETERGENT DOSING AND FINAL RINSE WERE SET ON THE DEVICE FOR ONE OF THE PROGRAMS. THE WASHER DISINFECTOR WAS USED IN THIS STATE WITHOUT ANY CORRECTION OF THE PROGRAM SETTINGS FOR ABOUT 1 YEAR. WE HAVE NO INFORMATION ABOUT ANY ADVERSE OUTCOME DUE TO THE ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, THAT ANY IMPROPERLY CLEANED LOADS USED FOR PATIENTS¿ TREATMENT COULD BE THE SOURCE OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458679 ↗

Other Getinge Disinfection AB products

• GETINGE 88-SERIES2 models · 6 reports · 3 recalls
• GETINGE CM320-SERIES6 models · 5 reports · 3 recalls
• Getinge Aquadis 562 models · 13 reports · 2 recalls
• GETINGE 46-SERIES3 models · 4 reports · 2 recalls
• GETINGE 9100-SERIES6 models · 17 reports · 1 recall