Events

Recall of Device Recall Getinge

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

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
    61974
  • Event Risk Class
    Class 2
  • Event Number
    Z-2079-2012
  • Event Initiated Date
    2012-05-25
  • Event Date Posted
    2012-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109621
  • 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 is voluntarily correcting washer disinfectors, getinge electrically heated 9100-series manufactured between 2009-05-04 through 09-26-2011. this action is based on a report from the ground fault breaker manufacturer of a production error.
  • Action
    Getinge USA issued a Device Correction Notice dated June 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to perform a trip test to determine if they have a functioning ground fault breaker. Customers will be contacted by a Getinge representative to schedule an appointment to exchange the earth fault breaker. Customers were provided a Customer Response Form to complete and fax back to 585-272-5033. For questions customers should call 800-475-9040, ext. 5270. For questions regarding this recall call 585-475-1400.

Device

Device Recall Getinge
  • Model / Serial
    Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada
  • Product Description
    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
  • Manufacturer
    Getinge USA Inc

Manufacturer

Getinge USA Inc
  • Manufacturer Address
    Getinge USA Inc, 1777 E Henrietta Rd, Rochester NY 14623-3133
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA