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PACIFIC LASERTECH, LLC recalls 25-LHP-928, HeNe Laser System, 25 mW
Recalled September 18, 2024 · FDA recall Z-2976-2024 · PACIFIC LASERTECH
Hazard
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. · FDA Class II
Units
4
Sold at
US Nationwide Distribution
Description
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.
Product
25-LHP-928, HeNe Laser System, 25 mW
Manufacturer(s)
PACIFIC LASERTECH, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →