Events

Recall of Solafeet Foot Tanner Model ST400

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Solafeet, 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
    54226
  • Event Risk Class
    Class 2
  • Event Number
    Z-0608-2010
  • Event Initiated Date
    2009-09-08
  • Event Date Posted
    2010-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87861
  • 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
    Suntan Lamp - Product Code REG
  • Reason
    Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.
  • Action
    Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or info@solafeet.com.

Device

Solafeet Foot Tanner Model ST400
  • Model / Serial
    Any codes associated with Model ST-400.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. || Use: feet tanner.
  • Manufacturer
    Solafeet, Inc.

Manufacturer

Solafeet, Inc.
  • Manufacturer Address
    Solafeet, Inc., W University Pkwy Unit A, Sarasota FL 34243-2742
  • Source
    USFDA