Date Initiated by Firm |
April 15, 2010 |
Date Posted |
September 10, 2010 |
Recall Status1 |
Terminated 3 on April 21, 2011 |
Recall Number |
Z-2349-2010 |
Recall Event ID |
56330 |
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Product Classification |
Powered Laser Surgical Instrument - Product Code GEX
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Product |
Picasso/Picasso Lite lasers
Intended use: Dentistry. |
Code Information |
All associated serial numbers. |
Recalling Firm/ Manufacturer |
AMD Lasers, LLC 7405 Westfield Blvd Indianapolis IN 46240
|
For Additional Information Contact |
317-202-9530
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Manufacturer Reason for Recall |
Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the Picasso/Picasso Lite lasers could be removed with force while the key was in the ON position.
|
FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
Letters, dated April 30, 2010, addressed to Dental Professionals were sent identifying the affected product and reason for the recall. The letter asked customers to check their units and, if applicable, AMD Lasers would replace the key assembly on their lasers. The service would be provided free of charge including round trip shipping charges to the corporate office. Customers are to call to schedule the service and obtain a RMA number and shipping instructions. Questions should be directed to 1-866-999-2635 or support@amdlasers.com. |
Quantity in Commerce |
3,000 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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