25-LHP-928, HeNe Laser System, 25 mW
FDA Recall Z-2976-2024 · Posted 2024-09-10
Recalling FirmPACIFIC LASERTECH, LLC
Recall StatusOpen, Classified
Product CodeRDW
Date Initiated2024-03-01
Product Quantity4
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.
Firm Action
The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.