FDA Medical Device Recalls (openFDA)
LAP of America Laser Applications, LLC: LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
- Recall number
- Z-1866-2014
- Recalling firm
- LAP of America Laser Applications, LLC
- Product
- LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
- Status
- Terminated
- Initiated
- 2014-03-21
- Posted
- 2014-06-24
- Terminated
- 2016-09-26
- Reason
- While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.
- Root cause
- Software design
- Action
- LAP of America Laser sent an Urgent safety Information FFST 2014-2-3 via UPS Next Day Air to the customer.
- Quantity
- 1 system
- Distribution
- North Carolina
- Lot, serial or model codes
- Product Code: 0007569-0001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 1000113153
- Firm city
- Boynton Beach
- Firm state
- FL
- 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