Date Initiated by Firm |
February 15, 2011 |
Date Posted |
April 12, 2011 |
Recall Status1 |
Terminated 3 on October 02, 2012 |
Recall Number |
Z-1844-2011 |
Recall Event ID |
58076 |
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Product Classification |
ophthalmic laser - Product Code HQF
|
Product |
Ellex Solo LT5106-S ophthalmic laser (not sold in USA) |
Code Information |
Units manufactured between August 2007 and 20 February 2011. |
Recalling Firm/ Manufacturer |
Ellex Medical Pty Ltd 82 Gilbert Street Adelaide Australia
|
Manufacturer Reason for Recall |
Unintended laser emission while the user was moving the joystick for targeting.
|
FDA Determined Cause 2 |
Process control |
Action |
Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011. |
Quantity in Commerce |
193 units |
Distribution |
worldwide distribution |
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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