Events

Recall of Device Recall Isotechnology, Isobalance System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acacia Engineered Products LLC.

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
    48990
  • Event Risk Class
    Class 2
  • Event Number
    Z-2348-2008
  • Event Initiated Date
    2008-07-09
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72459
  • 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
    Vestibular analysis apparatus - Product Code LXV
  • Reason
    The firm distributed an unapproved medical device.
  • Action
    On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.

Device

Device Recall Isotechnology, Isobalance System
  • Model / Serial
    Serial numbers: 07-001 through 07-030.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
  • Product Description
    Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
  • Manufacturer
    Acacia Engineered Products LLC

Manufacturer

Acacia Engineered Products LLC
  • Manufacturer Address
    Acacia Engineered Products LLC, 1108 Harpeth Industrial Ct, Franklin TN 37064-2224
  • Manufacturer Parent Company (2017)
    Acacia Engineered Products
  • Source
    USFDA