25-LHP-828, HeNe Laser System, 35 mW
This recall is currently active, issued September 10, 2024. It was issued by Pacific Lasertech, Llc.
- Company
- Pacific Lasertech, Llc
- Recall Initiated
- March 1, 2024
- Posted
- September 10, 2024
- Recall Number
- Z-2975-2024
- Quantity
- 4
- Firm Location
- San Marcos, CA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
25-LHP-828
Root Cause
Radiation Control for Health and Safety Act
Action Taken
The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.