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Recall Observatory FDA recall evidence

Device 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.

Z-1866-2014

March 21, 2014

Class II

Product summary

Firm
LAP of America Laser Applications, LLC
Event
Event 68259
Status
Terminated
Classification
Class II
Quantity
1 system
Official record key
device-enforcement:Z-1866-2014

Official wording

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.

Code information: Product Code: 0007569-0001

Distribution pattern: North Carolina

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.