FDA Device recall Z-2977-2024
N-LHP-928, HeNe Laser System, 35 mW
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of N-LHP-928, HeNe Laser System, 35 mW by Pacific Lasertech, citing 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-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2977-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-01 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Pacific Lasertech |
| Distribution | US |
Product
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.
Identifiers
| code_info | N-LHP-928 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2977-2024%22
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