HeNe laser system recalled for removable key safety control defect
Pacific Lasertech is recalling the N-LHP-928 HeNe Laser System (35 mW) because the key-actuated safety control can be removed while the laser is operating, defeating the required master control mechanism.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a safety-control bypass on a laser system with no reported injuries or illnesses. It qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Pacific Lasertech, LLC is recalling the N-LHP-928 HeNe Laser System, a 35 megawatt laser product distributed nationwide. The recalled units fail to comply with FDA safety regulations for laser classification systems.
The laser systems do not comply with 21 CFR 1040.10(f)(4), which requires that Class IIIb and IV laser products incorporate a key-actuated master control with a removable key that prevents operation when the key is removed. In these units, the key can be removed from the key switch while the laser is switched on, defeating this required safety feature.
Approximately 32 units were distributed nationwide. The manufacturer is correcting the defect by replacement with a key switch that captures and retains the key when the laser is in the on position.
The recalled product
- Product
- N-LHP-928, HeNe Laser System, 35 mW
- Manufacturer
- PACIFIC LASERTECH, LLC
- Category
- Medical Device — Laser Equipment
- Affected units
- 32
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)
- N-LHP-928
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by PACIFIC LASERTECH, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · PACIFIC LASERTECH, LLC
See all →- HighHeNe Laser System Key Control Can Be Removed While Operating
FDA (Devices) · 2024-09-18
- HighHeNe Laser System Allows Key Removal While Operating
FDA (Devices) · 2024-09-18
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