Class 2 Device Recall Weber SolarJet S Marking Unit

• Date Initiated by Firm: September 12, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• FEI Number: 1000298911
• Recalling Firm/ Manufacturer: Weber Marking System Inc.; 711 W Algonquin Rd; Arlington Heights IL 60005-4457
• For Additional Information Contact: Mr. Chris Brown; 847-879-3404
• 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: Other
• 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.