Medical Device Recall: 25-LHP-928, HeNe Laser System, 25 mW
PACIFIC LASERTECH, LLC · March 1, 2024
Reason for Recall
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.
Distribution
US Nationwide Distribution
States Affected
NATIONWIDE
Quantity Affected
4
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2976-2024
Status: ongoing
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