The Recall Desk
HighFDA (Devices)·Z-2977-2024·Announced 2024-09-18

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.

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: 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
Hazard
  • key-control-defect
  • safety-bypass

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.

Related recalls

Same category