CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

Lap Laser Pictor 3D Multi Color Laser System Pictor 3D is recalled

LAP of America Laser Applications is recalling Lap Laser Pictor 3D Multi Color Laser System Pictor 3D is a Lap laser system which uses, distributed in North Carolina. The recall was initiated on 21 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 0007569-0001

Quantity recalled1 system

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1866-2014
FDA event ID: 68259
Recalling firm: LAP of America Laser Applications, Boynton Beach, FL
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2014
FDA classified: 24 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Mar 2014	Recall initiated by company
24 Jun 2014	Classified by FDA	+95 days
2 Jul 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

North Carolina

Questions about this recall

Is Lap Laser Pictor 3D Multi Color Laser System Pictor 3D is a Lap laser system which uses recalled?

Yes. LAP of America Laser Applications recalled Lap Laser Pictor 3D Multi Color Laser System Pictor 3D is a Lap laser system which uses on 21 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1866-2014.

Why was it recalled?

Which lots are affected?

Product Code: 0007569-0001

Where was it sold?

North Carolina

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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