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U.S. Department of Health and Human Services

Class 2 Device Recall Picasso/Picasso Lite lasers

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 Class 2 Recall
Picasso/Picasso Lite lasers
see related information
Date Posted September 10, 2010
Recall Status1 Terminated on April 21, 2011
Recall Number Z-2349-2010
Recall Event ID 56330
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Picasso/Picasso Lite lasers Intended use: Dentistry.
Code Information All associated serial numbers.
Recalling Firm/
Manufacturer
AMD Lasers, LLC
7405 Westfield Blvd
Indianapolis, Indiana 46240
Consumer Instructions Contact the recalling firm for information
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: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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