Recall Z-2977-2024 ยท RDW General Purpose Laser Products
PACIFIC LASERTECH, LLC
N-LHP-928, HeNe Laser System, 35 mW
| Date | Sep 10, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge. |
| Quantity | 32 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.