Events

Recall of Device Recall System 83 Plus 2 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
    74311
  • Event Risk Class
    Class 2
  • Event Number
    Z-2130-2016
  • Event Initiated Date
    2016-05-06
  • Event Date Posted
    2016-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147130
  • 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
    Washer, cleaner, automated, endoscope - Product Code NVE
  • Reason
    To warn customers that custom ultrasonics, inc. system 83 plus aers should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
  • Action
    Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer." For questions regarding this recall call 215-364-1477.

Device

Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.
  • Product Description
    The System 83 Plus, Endoscope Washer/Disinfector || Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
  • 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