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U.S. Department of Health and Human Services

Class 2 Device Recall Weber SolarJet S Marking Unit

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  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/
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 2		 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.
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