Events

Recall of Device Recall RevLite SI Laser

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

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
    65407
  • Event Risk Class
    Class 2
  • Event Number
    Z-1599-2013
  • Event Initiated Date
    2013-05-09
  • Event Date Posted
    2013-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118789
  • 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
    An inconsistency was identified related to electronic display identification of the optional multilite dye handpieces of the revlite si laser system that may confuse user.
  • Action
    The firm, Cynosure Inc., sent a "MEDICAL DEVICE FIELD ACTIONS NOTIFICATION" letter dated May 9, 2013 to its customers via UPS next day. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the Revlite SI Multilite Dye Handpieces upon receipt of this letter and complete and return the enclosed Field Corrective Action Acknowledgement Form via e-mail to: mflynn@cynosure.com or FAX to: 978-256-6556. A Cynosure representative will be contacting customers to schedule and arrange an exchange of the affected handpieces. If additional information is required please contact VP of Regulatory Affairs and Quality Systems at 978-367-2350 or via email at ikulinets@cynosure.com.

Device

Device Recall RevLite SI Laser
  • Model / Serial
    659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
  • Product Description
    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. || The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. || Manufactured by: || ConBio, A Cynosure Company || 47733 Fremont blvd || Fremont, CA 94538
  • Manufacturer
    ConBio, a CynoSure Company

Manufacturer

ConBio, a CynoSure Company
  • Manufacturer Address
    ConBio, a CynoSure Company, 47733 Fremont Blvd, Fremont CA 94538-6512
  • Source
    USFDA