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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.

FDA Recall Z-1866-2014 · Posted 2014-06-24

Recalling FirmLAP of America Laser Applications, LLC
Recall StatusTerminated
Product CodeN/A
Date Initiated2014-03-21
Date Terminated2016-09-26
Product Quantity1 system

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.

Firm Action

LAP of America Laser sent an Urgent safety Information FFST 2014-2-3 via UPS Next Day Air to the customer.

Root Cause

Software design

Distribution Pattern

North Carolina

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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