FDA Enforcement
Class II
Ongoing
25-LHP-928, HeNe Laser System, 25 mW
Recall: Z-2976-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-2976-2024
- Event ID
- 95290
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PACIFIC LASERTECH, LLC
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- September 18, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- September 10, 2024
- Address
- 215 Bingham Dr # 110, San Marcos, CA, 92069-1403, United States
Description
25-LHP-928, HeNe Laser System, 25 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.
Code Info
25-LHP-928
Distribution
US Nationwide Distribution
Quantity
4