GETINGE 9100-SERIESRecalls & reported problems across all models
Getinge Disinfection AB · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one GETINGE 9100-SERIES model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of GETINGE 9100-SERIES by Getinge Disinfection AB in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2017 and Jan 31, 2024 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (6 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
GETINGE 9100-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.
- Apr 1, 2022Open, Classified
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
Z-1078-2022 · Root cause: Other · names 6 of these models · Recall details · FDA record ↗
Most reported GETINGE 9100-SERIES problems
Device problems
- Device Handling Problem6
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component2
- Device Fell2
- Leak/Splash2
- Contamination /Decontamination Problem1
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Bruise/Contusion4
- Muscle/Tendon Damage4
- Loss of Range of Motion2
- No Consequences Or Impact To Patient2
- No Patient Involvement1
GETINGE 9100-SERIES models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GETINGE 9100-SERIES 9128EDisinfector, Medical Devices1 recall10 reports
- GETINGE 9100-SERIES 9125EDisinfector, Medical Devices1 recall3 reports
- GETINGE 9100-SERIES 9120EDisinfector, Medical Devices1 recall2 reports
- GETINGE 9100-SERIES 9127EDisinfector, Medical Devices1 recall2 reports
- GETINGE 9100-SERIES 9122EWDisinfector, Medical Devices1 recall0 reports
- GETINGE 9100-SERIES 9128EWDisinfector, Medical Devices1 recall0 reports
Recent GETINGE 9100-SERIES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Device Fell; Device Fell
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18612193 ↗MalfunctionJan 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON DECEMBER 8TH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE 91E-SERIES WASHER DISINFECTOR, WITH THE MODEL NAME 9128E. AS IT WAS STATED DEBRIS WAS ON THE INSTUMENTS. THERE WAS NO ALARM ON THE DEVICE. 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 18449613 ↗MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: Muscle/Tendon Damage
MAUDE report 18325077 ↗MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: Muscle/Tendon Damage
MAUDE report 18325073 ↗MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem
MalfunctionDec 14, 2023Device Handling Problem; Device Handling Problem
MalfunctionApr 7, 2023Device Fell; Misassembly During Maintenance/Repair; Device Fell; Misassembly During Maintenance/Repair
MalfunctionMar 24, 2023Mechanical Jam; Mechanical Jam
MANUFACTURER'S REFERENCE NUMBER: (B)(6).
Patient problems: Loss of Range of Motion
MAUDE report 16608667 ↗MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: Loss of Range of Motion; Muscle/Tendon Damage
MAUDE report 16608666 ↗MalfunctionDec 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 21ST NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUES RELATED TO MANUAL TROLLEY. THE MANUAL TROLLEY IS NOT REGISTERED AS A MEDICAL DEVICE, HOWEVER UPON THE SITUATION OCCURRENCE IT WAS USED WITH THE MEDICAL DEVICE WASHER DISINFECTOR WITH THE MODEL NAME 9128E. AS IT WAS STATED, THE LOADING TROLLEY ALMOST FELL ON THE FLOOR DUE TO A FAULTY STOP PIN THAT IS INSTALLED ON THE MANUAL TROLLEY TO PREVENTS THE LOADING TROLLEYS FROM FALLING OFF. THE MALFUNCTIONED PART WAS REPLACED AND THE MANUAL TROLLEY WAS RETURNED TO THE SERVICE IN FULL WORKING CONDITION. THERE WAS NO INJURY OR DAMAGE REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS LOADING TROLLEY FALLING TO THE FLOOR 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 15894321 ↗MalfunctionMar 19, 2022Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem
ON 2ND MARCH, 2022 GETINGE RECEIVED THE INFORMATION ABOUT THE EVENT WHICH WAS RELATED TO MANUAL TROLLEY UNIVERSAL WASH CART 2000 THAT IS USED WITH THE 91E-SERIES WASHER DISINFECTOR. AS IT WAS STATED ON (B)(6) 2022 AN OPERATOR REPORTED A BRUISE ON HIS FOOT DURING THE EXTRACTION OF THE INSTRUMENTS FROM THE HIGHEST SHELF OF THE TROLLEY. AFTER THE MEDICAL EXAMINATION THE OPERATOR WAS 7 DAYS OFF WORK TO RECOVER FROM THE INJURY. BASED ON THE AVAILABLE INFORMATION WE CANNOT CLASSIFY THE HEALTH IMPACT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS WE CANNOT CONFIRM THAT SIMILAR EVENTS COULD NOT CONTRIBUTED TO THE SERIOUS INJURY IF REOCUR.
Patient problems: Bruise/Contusion
MAUDE report 13820059 ↗MalfunctionMar 19, 2022Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem
ON 2ND MARCH, 2022 GETINGE RECEIVED THE INFORMATION ABOUT THE EVENT WHICH WAS RELATED TO THE MANUAL TROLLEY UNIVERSAL WASH CART 2000 USED WITH THE 91E-SERIES WASHER DISINFECTOR. AS IT WAS STATED ON (B)(6) 2021 AN OPERATOR REPORTED A STRAIN INJURY WHILE TOWING THE TROLLEY IN THE WASHING TUNNEL. THE OPERATOR REPORTED THAT THE WHEELS WERE STUCK IN THE GROOVES. AFTER THE MEDICAL EXAMINATION THE OPERATOR WAS 7 DAYS OFF WORK TO RECOVER FROM THE INJURY. BASED ON THE AVAILABLE INFORMATION WE CANNOT CLASSIFY THE HEALTH IMPACT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS WE CANNOT CONFIRM THAT SIMILAR EVENTS COULD NOT CONTRIBUTED TO THE SERIOUS INJURY IF REOCCUR.
Patient problems: Muscle/Tendon Damage
MAUDE report 13820049 ↗MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
MANUFACTURER REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12580029 ↗MalfunctionAug 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
MANUFACTURER REFERENCE NUMBER: (B)(6) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12318871 ↗MalfunctionMar 23, 2020Leak/Splash; Leak/Splash
MANUFACTURER REFERENCE NUMBER (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9864559 ↗
Other Getinge Disinfection AB products
All Getinge Disinfection AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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