FDAFDA · Food and drugs·Recall number Z-1866-2014
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.
Published July 2, 2014 · Recall initiated: March 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- LAP of America Laser Applications, LLC
- Distributor
- North Carolina
- Lot
- Product Code: 0007569-0001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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