Z-2349-2010

Picasso/Picasso Lite lasers

Name: Z-2349-2010 Picasso/Picasso Lite lasers
Creator: AMD Lasers, LLC
Published: 2010-04-15
License: https://open.fda.gov/license/

Cao Group, Inc. / initiated 2010-04-15 / Terminated

FDA source

AMD Lasers, LLC began a recall of Picasso/Picasso Lite lasers Intended use: Dentistry on 2010-04-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2349-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-09-10
Terminated: 2011-04-21
Recalling firm: Cao Group, Inc.
Product: Picasso/Picasso Lite lasers Intended use: Dentistry.
Product code: GEX Powered Laser Surgical Instrument
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 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 [email protected].
Quantity in commerce: 3,000 units
Distribution: Worldwide Distribution
Product codes and lots: All associated serial numbers.

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)