FDA Recall
Terminated
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: Z-1866-2014
·
Initiated March 21, 2014
Recall
- Recall Number
- Z-1866-2014
- Event Number
- 68259
- Firm
- LAP of America Laser Applications, LLC
- FEI Number
- 1000113153
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 21, 2014
- Posted
- June 24, 2014
- Terminated
- September 26, 2016
- Address
- 161 Commerce Rd, Ste 3, Boynton Beach, FL, 33426-9385
Description
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.
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.
Action
LAP of America Laser sent an Urgent safety Information FFST 2014-2-3 via UPS Next Day Air to the customer.
Distribution
North Carolina
Quantity
1 system