FDA Medical Device Recalls (openFDA)
AMD Lasers, LLC: Picasso/Picasso Lite lasers Intended use: Dentistry.
- Recall number
- Z-2349-2010
- Recalling firm
- AMD Lasers, LLC
- Product
- Picasso/Picasso Lite lasers Intended use: Dentistry.
- Status
- Terminated
- Initiated
- 2010-04-15
- Posted
- 2010-09-10
- Terminated
- 2011-04-21
- 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
- Lot, serial or model codes
- All associated serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3003258642
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28