HeNe Laser System Key Control Can Be Removed While Operating
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a defective safety control mechanism. No reported injuries or illnesses. The hazard involves a control failure that could potentially allow unintended laser operation, but no actual harm has been documented, making it a risk-of-harm product where injury has not yet been reported.
Plain-English summary
PACIFIC LASERTECH, LLC is recalling the 25-LHP-928, 25 mW HeNe Laser System due to a safety control defect. These laser systems fail to comply with federal laser safety regulations (21 CFR 1040.10(f)(4)), which require that Class IIIb or IV laser products must have a key-actuated master control. The key must be removable and the laser must not operate when the key is removed.
The defect: While the laser is switched on, the key can be removed from the key switch. This defeats the safety control and could allow unintended laser operation and potential eye exposure. Four units have been distributed nationwide in the US.
Affected consumers should immediately stop using the laser system and contact PACIFIC LASERTECH, LLC for a replacement unit with a corrected key switch that properly captures the key when the laser is in the on position. Do not operate the laser until it has been replaced.
The recalled product
- Product
- 25-LHP-928, HeNe Laser System, 25 mW
- Manufacturer
- PACIFIC LASERTECH, LLC
- Category
- Medical Device — Laser System
- Hazard
- safety-control-failure
- laser-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 25-LHP-928
Distribution
Distributed nationwide across the United States.
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