GETINGE 9100-SERIES 9127ERecalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 9127E · 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 07340153710054), received between Mar 23, 2020 and Oct 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 23, 2020Leak/Splash; Leak/Splash
MANUFACTURER REFERENCE NUMBER (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9864559 ↗
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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