GETINGE 9100-SERIES 9120ERecalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 9120E · Class 2
All models of GETINGE 9100-SERIES (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340153710023), received between Dec 4, 2017 and Mar 2, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 FDA recall record 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
- Misassembled1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2020Leak/Splash; Misassembled; Leak/Splash; Misassembled
MalfunctionDec 4, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON (B)(6) WE BECOME AWARE OF AN INCIDENT WHERE ONE OF OUR MEDICAL DEVICE WAS INVOLVED. PER INFORMATION PROVIDED BY THE CUSTOMER IT WAS ESTABLISHED THAT DURING PREVENTIVE MAINTENANCE PERFORMED ON THE 9100-SERIES WASHER DISINFECTOR THE TECHNICIAN WENT INSIDE THE WASHER CHAMBER TO CHECK AND CLEAN THE FILTERS OF THE CHAMBER AND DID NOT LOCK DOOR WITH KEY SWITCH. IN THE SAME TIME OPERATOR OF THE DEVICE STARTED THE CYCLE. TECHNICIAN WHO WAS INSIDE THE CHAMBER STOPPED MACHINE IMMEDIATELY AND AS A RESULT HE WAS SPLASHED WITH COLD WATER. 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 Consequences Or Impact To Patient
MAUDE report 7078692 ↗
Other Disinfector, Medical Devices devices
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls6 reports
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls0 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls3 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
- GETINGE 86-SERIES S-8668Getinge Disinfection AB · Disinfector, Medical Devices1 recall37 reports
- Getinge Aquadis 56 56MGetinge Disinfection AB · Disinfector, Medical Devices1 recall11 reports
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · Disinfector, Medical Devices1 recall10 reports
- AMSCO 7053HPCorporation Steris Canada · Disinfector, medical devices1 recall10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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