GETINGE 91-SERIES 9128Recalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 9128 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340153700161), received between May 21, 2024 and May 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 9TH MAY, 2024 GETINGE BECAME AWARE OF AN ISSUE RELATED TO ONE OF THE WASHER-DISINFECTORS, 9128. AS IT WAS STATED, THE RAMP FALL TO THE GROUND WHILE THE HOSPITAL STAFF WAS LOADING THE DEVICE. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY SERIOUS INJURY AS A CONSEQUENCE OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19357856 ↗
Other Disinfector, Medical Devices devices
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- 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
- AMSCO 7052HPCorporation Steris Canada · Disinfector, medical devices1 recall10 reports
- GETINGE 9100-SERIES 9128EGetinge Disinfection AB · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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