Class 2 Device Recall Coherent

• Date Initiated by Firm: March 30, 2004
• Date Posted: November 30, 2004
• Recall Status: Terminated on August 04, 2005
• Recall Number: Z-0360-04
• Recall Event ID: 30397
• Product Classification: unknown device name - Product Code L--22
• Product: Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.
• Code Information: All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092.
• FEI Number: 2916213
• Recalling Firm/ Manufacturer: Coherent, Inc.; 5100 Patrick Henry Dr; Santa Clara CA 95054-1112
• For Additional Information Contact: Scott H. Miller; 408-764-4170
• Manufacturer Reason for Recall: Software problem that may cause unintended emission of laser radiation.
• FDA Determined Cause: Other
• Action: On 3/30/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
• Quantity in Commerce: 75 units
• Distribution: The firm has distributed 75 units to 10 US and 6 foreign consignees locatedd in Canada, Germany, and Japan. There is one wholesale dealer client, Amersham Health, located in Durham, NC.

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.