Class 2 Device Recall PICTOR 3D

• Date Initiated by Firm: March 21, 2014
• Date Posted: June 24, 2014
• Recall Status: Terminated on September 26, 2016
• Recall Number: Z-1866-2014
• Recall Event ID: 68259
• Product Classification: PICTOR 3D - Product Code ooo
• 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.
• Code Information: Product Code: 0007569-0001
• FEI Number: 1000113153
• Recalling Firm/ Manufacturer: LAP of America Laser Applications, LLC; 161 Commerce Rd Ste 3; Boynton Beach FL 33426-9385
• For Additional Information Contact: Tom Gaudet; 561-416-9250
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: LAP of America Laser sent an Urgent safety Information FFST 2014-2-3 via UPS Next Day Air to the customer.
• Quantity in Commerce: 1 system
• Distribution: North Carolina

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.