Events

Recall of Device Recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Ultrasonics, 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
    65985
  • Event Risk Class
    Class 2
  • Event Number
    Z-0426-2014
  • Event Initiated Date
    2013-03-12
  • Event Date Posted
    2013-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121143
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Reason
    Certain system 83 plus 2 and system 83 plus 9 units running the windows 7 operating system were not fully validated prior to distribution.
  • Action
    A notification letter, dated February 26, 2013, was sent to direct accounts to inform them of the recall and that technicians would visit facilities to replace the Windows 7 operating system with an appropriately validated Windows XP operating system.

Device

Device Recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector
  • Model / Serial
    Multiple serial numbers
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
  • Product Description
    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
  • Manufacturer
    Custom Ultrasonics, Inc.

Manufacturer

Custom Ultrasonics, Inc.
  • Manufacturer Address
    Custom Ultrasonics, Inc., 144 Railroad Dr, Ivyland PA 18974-1449
  • Manufacturer Parent Company (2017)
    Custom Ultrasonics Inc
  • Source
    USFDA