Events

Recall of Device Recall Fraxel re:store Dual 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
    57595
  • Event Risk Class
    Class 2
  • Event Number
    Z-1010-2011
  • Event Initiated Date
    2010-12-15
  • Event Date Posted
    2011-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96741
  • 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
    The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
  • Action
    The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.

Device

Device Recall Fraxel re:store Dual Laser System
  • Model / Serial
    Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
  • Product Description
    Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. || Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA || The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
  • 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