FDA Recall
Open, Classified
N-LHP-928, HeNe Laser System, 35 mW
Recall: Z-2977-2024
·
Initiated March 1, 2024
Recall
- Recall Number
- Z-2977-2024
- Event Number
- 95290
- Firm
- PACIFIC LASERTECH, LLC
- FEI Number
- 3015195092
- Product Code
- RDW
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- March 1, 2024
- Posted
- September 10, 2024
- Address
- 215 Bingham Dr, # 110, San Marcos, CA, 92069-1403
Description
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.
Action
The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.
Distribution
US Nationwide Distribution
Quantity
32