Events

Recall of Device Recall System 83 Plus WasherDisinfector

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
    46877
  • Event Risk Class
    Class 2
  • Event Number
    Z-1182-2008
  • Event Initiated Date
    2008-02-11
  • Event Date Posted
    2008-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68362
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Endoscope Washer-Disinfector - Product Code KOG
  • Reason
    Inadvertent selection of the "wash" cycle.
  • Action
    The recalling firm issued a Product Correction letter dated 2/11/08 to its customers informing them of the problem and the correction choices. The letter states that a key cover is available to reduce the error in the future and will be provided to each users upon return of the recall letter notification questionnaire.

Device

Device Recall System 83 Plus WasherDisinfector
  • Model / Serial
    All Serial Numbers
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide; USA medical facilities and physicians and Canada
  • Product Description
    System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
  • 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