GETINGE 46-SERIESRecalls & reported problems across all models

We found 3 models of GETINGE 46-SERIES by Getinge Disinfection AB in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2021 and Oct 31, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GETINGE 46-SERIES recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 ↗

2. 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-1390-2020 · Root cause: Employee error · Recall details · FDA record ↗

Most reported GETINGE 46-SERIES problems

GETINGE 46-SERIES models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GETINGE 46-SERIES 46-4

  Disinfector, Medical Devices
  1 recall2 reports
• GETINGE 46-SERIES 46-4

  Disinfector, Medical Devices
  1 recall1 report
• GETINGE 46-SERIES 46-5

  Disinfector, Medical Devices
  1 report

Recent GETINGE 46-SERIES adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579666 ↗
• 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 ↗
• 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 ↗
• 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 Getinge Disinfection AB products

• GETINGE 88-SERIES2 models · 6 reports · 3 recalls
• GETINGE CM320-SERIES6 models · 5 reports · 3 recalls
• Getinge Aquadis 562 models · 13 reports · 2 recalls
• GETINGE 86-SERIES5 models · 39 reports · 1 recall
• GETINGE 9100-SERIES6 models · 17 reports · 1 recall