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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 Coherentsee related information
Date Initiated by FirmJanuary 19, 2004
Date PostedNovember 16, 2004
Recall Status1 Terminated 3 on August 04, 2005
Recall NumberZ-0540-04
Recall Event ID 30415
Product Classification unknown device name - Product Code L22
ProductCoherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.
Code Information The following Model---Serial Numbers (S/N) are affected:  P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 ¿ S/Ns 10019, 10019, 10020, 10043, and 10052. 
FEI Number 2916213
Recalling Firm/
Manufacturer		 Coherent, Inc.
5100 Patrick Henry Dr
Santa Clara CA 95054-1112
For Additional Information ContactScott H. Miller
408-764-4170
Manufacturer Reason
for Recall		Software problem that may cause unintended emission of laser radiation.
FDA Determined
Cause 2		Other
ActionOn 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Quantity in Commerce93 units
Distribution10 US customers and 6 foreign customers in Canada, Germany, Japan received this product, with 1 wholesale dealer in Amersham Health, 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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