Device product
25-LHP-828, HeNe Laser System, 35 mW
Z-2975-2024
Product summary
- Event
- Event 95290
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-2975-2024
Official wording
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 information: 25-LHP-828
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.