Events

Recall of Device Recall Getinge 86 Series with G1 control system software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Getinge Disinfection Ab.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71777
  • Event Risk Class
    Class 3
  • Event Number
    Z-2419-2015
  • Event Initiated Date
    2015-06-26
  • Event Date Posted
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139032
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Disinfector, medical devices - Product Code MEC
  • Reason
    Getinge disinfection ab has initiated a field correction due to the potential for unauthenticated remote access to the product over the network.
  • Action
    Getinge Disinfection AB has initiated a Field Correction due to unauthenticated remote access to the product over the network.

Device

Device Recall Getinge 86 Series with G1 control system software
  • Model / Serial
    Software versions up to and including 1.5.1.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
  • Product Description
    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
  • Manufacturer
    Getinge Disinfection Ab

Manufacturer

Getinge Disinfection Ab
  • Manufacturer Address
    Getinge Disinfection Ab, Ljungadalsgatan 11, Vaxjo Sweden
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA