Events

Recall of Device Recall Candela Corporation Vbeam Aesthetica Laser System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Candela Laser 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
    37180
  • Event Risk Class
    Class 2
  • Event Number
    Z-0508-2007
  • Event Initiated Date
    2007-01-15
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50053
  • 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
    Laser System - Product Code GEX
  • Reason
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Action
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.

Device

Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Model / Serial
    9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
  • Product Description
    Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display
  • Manufacturer
    Candela Laser Corporation

Manufacturer

Candela Laser Corporation
  • Manufacturer Address
    Candela Laser Corporation, 530 Boston Post Rd, Wayland MA 01778-1833
  • Source
    USFDA