Z-1866-2014Class II

LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection...

Name: Z-1866-2014 LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection...
Creator: LAP of America Laser Applications, LLC
Published: 2014-03-21
License: https://open.fda.gov/license/

LAP of America Laser Applications, LLC. / initiated 2014-03-21 / Terminated / root cause: software

FDA source

LAP of America Laser Applications, LLC began a recall of 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... on 2014-03-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1866-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-21
Posted: 2014-06-24
Terminated: 2016-09-26
Recalling firm: LAP of America Laser Applications, LLC.
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.
Product code: N/A
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.
Root cause tag: software
FDA root 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
Product codes and lots: Product Code: 0007569-0001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1866-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)