• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Weber SolarJet S Marking Unit

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Weber SolarJet S Marking Unit see related information
Date Initiated by Firm September 12, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 29, 2004
Recall Number Z-0153-04
Recall Event ID 28383
Product Classification unknown device name - Product Code LS-99
Product Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington Heights, IL 60005
Code Information serial number 09333451
Recalling Firm/
Weber Marking System Inc.
711 W Algonquin Rd
Arlington Heights IL 60005-4457
For Additional Information Contact Mr. Chris Brown
Manufacturer Reason
for Recall
The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report.
FDA Determined
Cause 2
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.
Quantity in Commerce 1 unit
Distribution Virginia

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.