LAP Laser Pictor 3D System Recalled for Projection Splitting
LAP of America is recalling one Laser Pictor 3D system in North Carolina because the yellow projection line can split into red and green lines, causing a 2.5mm deviation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a projection deviation of up to 2.5mm, which is a functional defect but does not meet the criteria for Severe (4) as there are no reports of hospitalization or significant injury, nor is it a structural defect leading to immediate serious harm.
Plain-English summary
LAP of America Laser Applications, LLC is recalling one unit of the LAP Laser Pictor 3D Multi Color Laser System. The recall is limited to North Carolina. The product code for the affected unit is 0007569-0001.
The recall was initiated because the yellow projection line on the device has the potential to split into two separate red and green projections. When this occurs, the difference between the red and green projections can be up to 2.5mm. This deviation may affect the accuracy of the laser system's projections.
The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall. No illnesses or injuries are reported in the source text.
The recalled product
- 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.
- Manufacturer
- LAP of America Laser Applications, LLC
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: 0007569-0001
Distribution
Distributed in 1 state:
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