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Open, Classified

N-LHP-928, HeNe Laser System, 35 mW

FDA Recall Z-2977-2024 · Posted 2024-09-10

Recalling FirmPACIFIC LASERTECH, LLC
Recall StatusOpen, Classified
Product CodeRDW
Date Initiated2024-03-01
Product Quantity32

Reason for Recall

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.

Firm Action

The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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