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Terminated

Picasso/Picasso Lite lasers Intended use: Dentistry.

FDA Recall Z-2349-2010 · Posted 2010-09-10

Recalling FirmAMD Lasers, LLC
Recall StatusTerminated
Product CodeGEX
Date Initiated2010-04-15
Date Terminated2011-04-21
Product Quantity3,000 units

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.

Firm 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 [email protected].

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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