Z-1866-2014 Class II Terminated

Recalled by LAP of America Laser Applications, LLC — Boynton Beach, FL

Recall Details

Product Type
Devices
Report Date
July 2, 2014
Initiation Date
March 21, 2014
Termination Date
September 26, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 system

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.

Distribution Pattern

North Carolina

Code Information

Product Code: 0007569-0001