Events

Recall of Device Recall StarBurst

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rita Medical Systems, Inc..

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
    35342
  • Event Risk Class
    Class 2
  • Event Number
    Z-0888-06
  • Event Initiated Date
    2006-05-02
  • Event Date Posted
    2006-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45894
  • 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
    Electrosurgical - Product Code GEI
  • Reason
    Misbranding; product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
  • Action
    Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.

Device

Device Recall StarBurst
  • Model / Serial
    Catalog number: 700-103027, Lot number 25952
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
  • Product Description
    XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst¿ Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA¿ * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
  • Manufacturer
    Rita Medical Systems, Inc.

Manufacturer

Rita Medical Systems, Inc.
  • Manufacturer Address
    Rita Medical Systems, Inc., 1 Horizon Way, Manchester GA 31816-1749
  • Source
    USFDA