GETINGE 9100-SERIES 9125ERecalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 9125E · Class 2
Data updated Oct 13, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340153710047), received between Mar 24, 2023 and Jan 31, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Fell” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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 · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Fell1
- Mechanical Jam1
Patient problems
- Loss of Range of Motion2
- Muscle/Tendon Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗
Other Disinfector, Medical Devices devices
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- 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
- 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 · each recall links to the FDA recall notice
- 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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