[Recalled] N-LHP-928, HeNe Laser System, 35 mW — These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which… | FDA 2024-03-01
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | N-LHP-928, HeNe Laser System, 35 mW |
|---|---|
| Brand / manufacturer | PACIFIC LASERTECH, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2977-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 March 2024 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from PACIFIC LASERTECH, LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.