Class 2 Device Recall Ellex Integre Duo

• Date Initiated by Firm: June 13, 2007
• Date Posted: December 20, 2007
• Recall Status: Terminated on October 17, 2008
• Recall Number: Z-0287-2008
• Recall Event ID: 45499
• 510(K)Number: K052777
• Product Classification: Opthalmic Laser - Product Code HQF
• Product: Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
• Code Information: Integre Duo LP1RG-S P/N 3040000 (serial # /system #): 31418 / ID1057
• Recalling Firm/ Manufacturer: Ellex USA; 7138 Shady Oak Road; Eden Prairie MN 55344
• For Additional Information Contact: 952-881-9100
• Manufacturer Reason for Recall: Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.
• FDA Determined Cause: Device Design
• Action: Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.
• Quantity in Commerce: 1
• Distribution: Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = HQF