Events

Safety Alert for Fraxel re:store Dual Laser System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Solta Medical Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-02-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110211.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Safety concern on fraxel re:store dual laser systemthe department of health (dh) today (february 11) warned healthcare professionals and beauty industry operators that the fraxel re:store dual laser system runs the risk of causing inadvertent laser firing which may lead to patient/operator injury. dh, through its routine surveillance on medical devices, noticed that the us food and drug administration (fda) has announced that the product’s manufacturer, solta medical inc., is recalling all the affected devices for corrective actions. fraxel re:store dual laser system is a laser surgical instrument for use in general and plastic surgery and in dermatology. a dh spokesman said: "there is a risk of causing skin burn under high energy setting and small spot size." the model numbers and serial numbers of the devices involved are - 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 serial numbers: f1196j, j0007, j0010-j0058, j0060-j0203, j0205, j0207-j0209, j0211-j0337, j0339-j0359, j0361-j0414, j0417-j0419, j0426 according to the information from local supplier, solta medical inc., at least three machines were imported to hong kong. two were sold to local healthcare professionals and one was used as a demonstration machine. the supplier has contacted the local users for immediate corrective actions. so far, the dh has not received any report of adverse events arising from use of the affected products. dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant. while dh will continue to monitor the development, the spokesman urged healthcare professionals and operators of beauty parlours who are using the affected device to stop using it, and contact the local supplier for immediate corrective actions. ends/friday, february 11, 2011.

Device

Fraxel re:store Dual Laser System
  • Model / Serial
  • Product Description
    Press release: Safety concern on Fraxel re
  • Manufacturer
    Solta Medical Inc.

Manufacturer

Solta Medical Inc.