Pacific LaserTech recalls 25-LHP-828 HeNe Laser Systems (35 mW) due to key safety failure. The laser can be operated without a key, risking injury. Affected users should stop using and contact for replacement.
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 25-LHP-828 HeNe Laser Systems (35 mW) because the key can be removed while the laser is on, allowing operation without the key. This poses a risk of injury if the laser is accidentally activated.
The laser system lacks a key that must stay in place when the device is on. If the key is removed while the laser is active, the device can be operated without the key, potentially causing injury.
Users of the 25-LHP-828 HeNe Laser System (35 mW) are affected. Those using the laser in environments where accidental activation could occur are at higher risk.
Check for the model number 25-LHP-828 on the laser system. The product was sold as a 35 mW HeNe Laser System.
Immediately stop using the 25-LHP-828 HeNe Laser System if the key can be removed while the laser is on.
Yes, the laser can be operated without the key, which poses a risk of injury if accidentally activated.
Check for the model number 25-LHP-828 on the laser system. The product was sold as a 35 mW HeNe Laser System.
Stop using it now and contact Pacific LaserTech for a replacement.
We’ve drafted a message you can send Pacific LaserTech to request your refund or repair — edit it as you like.
Subject: Recall Z-2975-2024 — Pacific LaserTech Pacific LaserTech Hello, I own a Pacific LaserTech that is covered by recall Z-2975-2024 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.
