Events

Recall of Device Recall Candela Laser

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

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
    66773
  • Event Risk Class
    Class 2
  • Event Number
    Z-0348-2014
  • Event Initiated Date
    2013-11-06
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123370
  • 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 - Product Code GEX
  • Reason
    Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
  • Action
    Candela notiifed Distributors on 11/8/13 through e-mail, Certified return receipt request, or FedEx package containing distributor letter, customer letter for translation and customer lists. A software update to Version 2.0 will be issued to the user by a field service representative.

Device

Device Recall Candela Laser
  • Model / Serial
    GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
  • Product Description
    Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. || and Candela Laser GentleLase Pro LE, || Model number: 9914-00-9040
  • Manufacturer
    Candela Corporation

Manufacturer

Candela Corporation
  • Manufacturer Address
    Candela Corporation, 530 Boston Post Rd, Wayland MA 01778-1833
  • Manufacturer Parent Company (2017)
    Apax Partners Llp
  • Source
    USFDA