GETINGE 46-SERIES 46-4 (REF 46-4-503)Recalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 46-4-403 D+WD, D+WD indicating double door + dryer. Cat no was 46-4-403. From March 2019 new cat no is 46-4-503. · Class 2
All models of GETINGE 46-SERIES (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07340153700048), received between Feb 4, 2021 and Jan 5, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 FDA recall record name this device's identifier.
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
- Jan 16, 2020Terminated
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Z-1391-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
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.
MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON DECEMBER 21ST, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH THE 46-SERIES WASHER DISINFECTOR. AS IT WAS STATED THE MACHINE DOOR FELL. THERE WAS NO INFORMATION ABOUT ANY INJURY PROVIDED, HOWEVER WE DECIDED TO REPORT THIS CASE BASED ON THE POTENTIAL AS DOOR FALLING TO THE FLOOR COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO A SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101120 ↗MalfunctionFeb 4, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
MANUFACTURER REFERENCE NUMBER (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11279025 ↗
Other Disinfector, Medical Devices devices
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- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
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- 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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