Events

Recall of FRAXEL RE:STORE DUAL LASER SYSTEM - CONSOLE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    47200
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Report of patient and operator experiensing burns as a result of inadvertent firing of a fraxel re:store dual laser system because of short circuit within the laser module.

Device

FRAXEL RE:STORE DUAL LASER SYSTEM - CONSOLE
  • Model / Serial
    Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-UPG-INTL); Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-INTL); Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-I-LOANER); Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-US); Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-US-LOANER); Model Catalog: MC-SYS-SR1500-D-INTL (Lot serial: MC-SYS-SR1500-D-UPG-US)
  • Product Description
    FRAXEL RE:STORE DUAL LASER SYSTEM- Console
  • Manufacturer
    SOLTA MEDICAL INC.

Manufacturer

SOLTA MEDICAL INC.