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PACIFIC LASERTECH Recalls
3 recalls on record · September 18, 2024 to September 18, 2024 · Medical Devices
September 18, 2024Medical DevicesFDA
PACIFIC LASERTECH, LLC recalls N-LHP-928, HeNe Laser System, 35 mW
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.
September 18, 2024Medical DevicesFDA
PACIFIC LASERTECH, LLC recalls 25-LHP-928, HeNe Laser System, 25 mW
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.
September 18, 2024Medical DevicesFDA
PACIFIC LASERTECH, LLC recalls 25-LHP-828, HeNe Laser System, 35 mW
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.