HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)
Laser product non-compliance with key control can increase the risk of unauthorized or accidental laser operation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
25-LHP-928, HeNe Laser System, 25 mW
Brand
PACIFIC LASERTECH, LLC
Lot Codes / Batch Numbers
25-LHP-928
Products Sold
25-LHP-928
PACIFIC LASERTECH, LLC is recalling 25-LHP-928, HeNe Laser System, 25 mW due to 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 pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026