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Class 2 Device Recall Ellex Solitarie Opthalmic Laser System |
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Date Initiated by Firm |
June 13, 2007 |
Date Posted |
December 20, 2007 |
Recall Status1 |
Terminated 3 on October 17, 2008 |
Recall Number |
Z-0286-2008 |
Recall Event ID |
45499 |
510(K)Number |
K041598
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Product Classification |
Ophthalmic Laser - Product Code HQF
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Product |
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
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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
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For Additional Information Contact |
952-881-9100
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Manufacturer Reason for Recall |
Electric Shock from Power Supply : The power supply has a defect which can cause an electrical shock to user.
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = HQF and Original Applicant = Ellex Medical Pty. Ltd.
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