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U.S. Department of Health and Human Services

Class 2 Device Recall Ellex Motorised Safety Filter

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  Class 2 Device Recall Ellex Motorised Safety Filter see related information
Date Initiated by Firm February 11, 2009
Date Posted January 20, 2010
Recall Status1 Terminated 3 on September 07, 2012
Recall Number Z-0577-2010
Recall Event ID 54019
Product Classification Ophthalmic Laser - Product Code HQF
Product Ellex Motorised Safety Filter, Zeiss; Model number 6339585.

Intended for photocoagulation.
Code Information Solitaire LP4532 photocoagulator.
Recalling Firm/
Manufacturer		 Ellex Medical Pty Ltd
82 Gilbert Street
Adelaide Australia
Manufacturer Reason
for Recall		 Potential for two screws important in the design of the safety filter to come loose.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.
Quantity in Commerce 200 units total
Distribution Worldwide Distribution.
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.
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