PACIFIC LASERTECH, LLC recalls N-LHP-928, HeNe Laser System, 35 mW

Recall date

March 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2977-2024

FDA classification

Class II

Brand / firm

PACIFIC LASERTECH, LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

N-LHP-928, HeNe Laser System, 35 mW