Events

Recall of Weber SolarJet S Marking Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Weber Marking System 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
    28383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0153-04
  • Event Initiated Date
    2003-09-12
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31741
  • 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
    unknown device name - Product Code LS-99
  • Reason
    The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report.
  • Action
    Recalled by letter dated 9/12/03. The user account was advised of the labeling non-compliances and that a Weber Marking Systems representative would visit their location to correct the laser unit.

Device

Weber SolarJet S Marking Unit
  • Model / Serial
    serial number 09333451
  • Distribution
    Virginia
  • Product Description
    Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington Heights, IL 60005
  • Manufacturer
    Weber Marking System Inc.

Manufacturer

Weber Marking System Inc.
  • Manufacturer Address
    Weber Marking System Inc., 711 W Algonquin Rd, Arlington Heights IL 60005-4457
  • Source
    USFDA