Pacific LaserTech recalls N-LHP-928 HeNe Laser Systems due to key safety failure. The laser can be operated without the key, risking serious injury from unintended activation.
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.
Pacific LaserTech is recalling its N-LHP-928 HeNe Laser System (35 mW) because it lacks a key that must stay in place to prevent accidental activation. This could lead to serious injury if the laser turns on unexpectedly while the key is removed.
The laser system can be operated without the key being securely in place. If the key is removed while the laser is on, it could activate unexpectedly, potentially causing serious injury like burns or eye damage.
Users of the N-LHP-928 HeNe Laser System for scientific, medical, or educational purposes are affected. Those using the laser in settings where accidental activation could cause injury are at higher risk.
Check for the model number N-LHP-928 on the laser system. This product was sold by Pacific LaserTech and is a 35 mW HeNe Laser System.
Ensure the key remains securely in the key switch when the laser is on. If the key can be removed without triggering the laser, it is unsafe.
Yes, the laser can cause serious injury if accidentally activated. The key must stay in place to prevent unintended operation.
Look for the model number N-LHP-928 on the laser system. This product was sold by Pacific LaserTech as a 35 mW HeNe Laser System.
The official recall does not specify a replacement or return process. Check the key security to ensure it cannot be removed while the laser is on.
We’ve drafted a message you can send Pacific LaserTech to request your refund or repair — edit it as you like.
Subject: Recall Z-2977-2024 — Pacific LaserTech Pacific LaserTech Hello, I own a Pacific LaserTech that is covered by recall Z-2977-2024 from Pacific LaserTech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
