Recall Z-1866-2014— LAP of America Laser Applications, LLC
Class II · Terminated
Class II FDA medical device recall by LAP of America Laser Applications, LLC, initiated 2014-03-21, terminated 2016-09-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- LAP of America Laser Applications, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-21
- Terminated
- 2016-09-26
- Firm location
- Boynton Beach, FL, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.