Recall Z-2977-2024— PACIFIC LASERTECH, LLC
Class II · Ongoing
Class II FDA medical device recall by PACIFIC LASERTECH, LLC, initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: N-LHP-928, HeNe Laser System, 35 mW. Reason: 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..
- Recalling firm
- PACIFIC LASERTECH, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-01
- Firm location
- San Marcos, CA, United States
Product description
N-LHP-928, HeNe Laser System, 35 mW
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.