Events

Recall of Viking

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vision Systems Group, A Div of Viking Systems.

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
    37793
  • Event Risk Class
    Class 2
  • Event Number
    Z-0873-2007
  • Event Initiated Date
    2007-04-05
  • Event Date Posted
    2007-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51543
  • 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
    Light Source for Endoscopes - Product Code KOG
  • Reason
    Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure.
  • Action
    Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.

Device

Viking
  • Model / Serial
    Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to CA and NC
  • Product Description
    Light Source 300 Watt Xenon Lamp used in the following models: || Viking EndoSite Xenon, Model 8050-1 and || Boston Scientific Spyglass 300W Light Source (M00546190)
  • Manufacturer
    Vision Systems Group, A Div of Viking Systems

Manufacturer

Vision Systems Group, A Div of Viking Systems
  • Manufacturer Address
    Vision Systems Group, A Div of Viking Systems, 134 Flanders Rd, Westborough MA 01581-1023
  • Source
    USFDA