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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