Events

Recall of Device Recall 83 Miniflex with accesory crate

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
    37702
  • Event Risk Class
    Class 2
  • Event Number
    Z-0770-2007
  • Event Initiated Date
    2005-12-12
  • Event Date Posted
    2007-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51342
  • 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
    Accessory for cleaning endoscope - Product Code FEB
  • Reason
    The device was marketed without a 510k.
  • Action
    On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.

Device

Device Recall 83 Miniflex with accesory crate
  • Model / Serial
    Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
  • Product Description
    83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
  • 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