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U.S. Department of Health and Human Services

Class 2 Device Recall Coherent

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  Class 2 Device Recall Coherent see related information
Date Initiated by Firm March 30, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 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.
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 2		 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.
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