Class 2 Device Recall Ellex Solitarie Opthalmic Laser System

• Date Initiated by Firm: June 13, 2007
• Date Posted: December 20, 2007
• Recall Status: Terminated on October 17, 2008
• Recall Number: Z-0286-2008
• Recall Event ID: 45499
• 510(K)Number: K041598
• Product Classification: Ophthalmic Laser - Product Code HQF
• Product: Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
• Code Information: Solitaire-DGS P/N 303896 (serial # /system #): 31577 /4A2149, 32263 /4A2150, 32256 /4A2152, 32224 /4A2162, 32264 /4A2165, 32627 /4A2174D Solitarie-SGS P/N 3038960 serial # /system #): 31313 /4A2129, 32223 /4A2148, 32728 /4A2160, 32733 /4A2175S
• 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: 10
• 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