Class 2 Device Recall Coherent

• Date Initiated by Firm: November 17, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 08, 2005
• Recall Number: Z-0357-04
• Recall Event ID: 28434
• Product Classification: unknown device name - Product Code --
• Product: Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
• Code Information: Serial Numbers/Model Numbers: TFAP0004P--TFAP00048
• FEI Number: 2916213
• Recalling Firm/ Manufacturer: Coherent Inc Laser Group; 5100 Patrick Henry Dr; Santa Clara CA 95054-1112
• For Additional Information Contact: Scott H. Miller; 408-764-4594
• Manufacturer Reason for Recall: Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
• FDA Determined Cause: Other
• Action: On 11/7/03, all consignees were notified via Certified Mail and on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.
• Quantity in Commerce: 52 units
• Distribution: 52 units were released for distribution to consignees in U.S. nationally.

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.