Events

Recall of Device Recall Decomat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Getinge/Castle, 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
    26011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0908-03
  • Event Initiated Date
    2003-03-25
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26867
  • 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
    Hot water may splash from the washer chamber creating a burn hazard.
  • Action
    Letter dated 3/25/03 flagged: ''Important Safety Alert/Product Upgrade''. Customers advised to discontinue use until the field correction is performed.

Device

Device Recall Decomat
  • Model / Serial
    Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
  • Product Description
    Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
  • Manufacturer
    Getinge/Castle, Inc.

Manufacturer

Getinge/Castle, Inc.
  • Manufacturer Address
    Getinge/Castle, Inc., 1777 E Henrietta Road, Rochester NY 14623
  • Source
    USFDA