Events

Recall of Device Recall Thermage

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

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
    25383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-03
  • Event Initiated Date
    2002-12-09
  • Event Date Posted
    2003-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25712
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
  • Action
    The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.

Device

Device Recall Thermage
  • Model / Serial
    M00023,  M00024,  M00029, M00031, M00033R, M00034, M00035,
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. Government or Canadian distribution.
  • Product Description
    ThermaCool TC 1.0 cm2 Treatment Tip, || Single Patient Use Only
  • Manufacturer
    Thermage

Manufacturer

Thermage
  • Manufacturer Address
    Thermage, 4058 Point Eden Way, Hayward CA 94545-3721
  • Source
    USFDA