Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0153-04

Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington Heights, IL 60005

Weber Marking System Inc. / initiated 2003-09-12 / Terminated / root cause: labeling and UDI

Weber Marking System Inc. began a recall of Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington Heights, IL 60005 on . The reason FDA records is "The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0153-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Weber Marking System Inc.
Product
Weber SolarJet S CO2 Vector Laser Coder System; Weber Marking Systems, Inc., Arlington Heights, IL 60005
Product code
LS-99
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.
Root cause tag
labeling and UDI
FDA root 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
Product codes and lots
serial number 09333451