Events

Recall of Device Recall PICTOR 3D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LAP of America Laser Applications, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68259
  • Event Risk Class
    Class 2
  • Event Number
    Z-1866-2014
  • Event Initiated Date
    2014-03-21
  • Event Date Posted
    2014-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127229
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    PICTOR 3D - Product Code ooo
  • 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.
  • Action
    LAP of America Laser sent an Urgent safety Information FFST 2014-2-3 via UPS Next Day Air to the customer.

Device

Device Recall PICTOR 3D
  • Model / Serial
    Product Code: 0007569-0001
  • Distribution
    North Carolina
  • 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.
  • Manufacturer
    LAP of America Laser Applications, LLC

Manufacturer

LAP of America Laser Applications, LLC
  • Manufacturer Address
    LAP of America Laser Applications, LLC, 161 Commerce Rd Ste 3, Boynton Beach FL 33426-9385
  • Source
    USFDA