Events

Recall of Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. || Model Number: 9914-00-0300

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
    35221
  • Event Risk Class
    Class 2
  • Event Number
    Z-0842-06
  • Event Initiated Date
    2006-01-17
  • Event Date Posted
    2006-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45535
  • 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
    Leukotome - Product Code GXE
  • Reason
    Handle fires even when the finger is off the switch.
  • Action
    Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system.

Device

Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecolog...
  • Model / Serial
    Serial Number: SN 9998;  9914-0300-0001 through 9914-0300-0058
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, Spain, Japan, Germany, France, Switzerland
  • Product Description
    Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. || Model Number: 9914-00-0300
  • Manufacturer
    Candela Laser Corporation

Manufacturer

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