Recall of Device Recall Cardinal, Digital Bariatric Scale

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Scale Mfg Co.

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
    76975
  • Event Risk Class
    Class 2
  • Event Number
    Z-2217-2017
  • Event Initiated Date
    2015-12-23
  • Event Date Posted
    2017-06-01
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-06-28
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Scale, stand-on, patient - Product Code FRI
  • Reason
    One complaint of a seat on a scale failing unexpectedly which can cause an injury.
  • Action
    On 12/23/2015, the recalling firm sent a letter to their customers. The letter accompanied a kit to be installed immediately upon receipt. For assistance with installation contact technical service department at 866-254-8261.

Device

  • Model / Serial
    None.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide in the states: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, NEW JERSEY, New York, NORTH CAROLINA, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Product was also distributed to the following foreign countries: Canada, Hong Kong, Kuwait, Pakistan,
  • Product Description
    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
  • Manufacturer

Manufacturer