GETINGE 46-SERIES 46-5Recalls & reported problems
Getinge Disinfection AB · WASHER DISINFECTOR 46-5 D+W D, D+W D indicating double door machine with dryer. Cat no was 46-5-403. From March 2019 new cat no is 46-5-503. · Class 2
All models of GETINGE 46-SERIES (3)
Data updated Oct 16, 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 07340153700086), received between Jun 15, 2021 and Jun 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Fell1
- Material Twisted/Bent1
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.
MalfunctionJun 15, 2021Material Twisted/Bent; Device Fell; Material Twisted/Bent; Device Fell
ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WHERE THE GUIDE WAS BENT AND AS A CONSEQUENCE TOOL TRAY FELL DOWN NEAR THE OPERATOR. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON A POTENTIAL AS THE TRAY FALLING OFF THE TROLLEY COULD BRING A HAZARDOUS SITUATION FOR THE OPERATOR AND LEAD TO SERIOUS BODY INJURY IF THE SITUATION WAS TO REOCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11999249 ↗
Other Disinfector, Medical Devices devices
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- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
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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
- 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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