Pacific LaserTech recalls 25-LHP-928 HeNe Laser Systems due to key safety failure. The laser can be operated without a key, risking injury. Affected units may need 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-928 HeNe Laser Systems because the key can be removed while the laser is on, creating a risk of injury. This failure to meet safety standards means users could operate the laser without the key, potentially causing harm.
The laser system fails to require a key to be in place before operation. If the key is removed while the laser is on, the device can be operated without the key, increasing the risk of injury.
Users of the 25-LHP-928 HeNe Laser System are affected. Those using the laser for medical, educational, or industrial purposes are at higher risk due to the potential for injury.
Check for the model number 25-LHP-928 on the laser system. This product was sold as a 25 mW HeNe Laser System.
Ensure the key is securely locked in place before operating the laser. If the key can be removed while the laser is on, stop using it immediately.
Yes, the laser can be operated without a key, which increases the risk of injury.
Look for the model number 25-LHP-928 on the laser system.
Check if the key can be removed while the laser is on. If so, stop using it immediately 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-2976-2024 — Pacific LaserTech Pacific LaserTech Hello, I own a Pacific LaserTech that is covered by recall Z-2976-2024 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.
