Events

Recall of Device Recall Fraxel Laser System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Solta Medical, 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
    67835
  • Event Risk Class
    Class 2
  • Event Number
    Z-1463-2014
  • Event Initiated Date
    2014-03-20
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126461
  • 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
    Powered laser surgical instrument with microbeam\ fractional output - Product Code ONG
  • Reason
    Obsolete versions of the laser treatment settings card for the fraxel dual 1550/1927 laser system may have contained incorrect indication for use for treatment of melasma.
  • Action
    Solta Medical sent an Correction Important Product letter dated March 20, 2014 to affected customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form.

Device

Device Recall Fraxel Laser System
  • Model / Serial
    Model MC-SYS-SR1500-D, Revisions A and B.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
  • Manufacturer
    Solta Medical, Inc.

Manufacturer

Solta Medical, Inc.
  • Manufacturer Address
    Solta Medical, Inc., 25881 Industrial Blvd, Hayward CA 94545-2991
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA