Recall Z-2349-2010 ยท GEX Powered Laser Surgical Instrument
AMD Lasers, LLC
Picasso/Picasso Lite lasers Intended use: Dentistry.
| Date | Sep 10, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3,000 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.