Class 2 Device Recall NLHP928, HeNe Laser System, 35 mW

• Date Initiated by Firm: March 01, 2024
• Date Posted: September 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2977-2024
• Recall Event ID: 95290
• Product Classification: General purpose laser products - Product Code RDW
• Product: N-LHP-928, HeNe Laser System, 35 mW
• Code Information: N-LHP-928
• FEI Number: 3015195092
• Recalling Firm/ Manufacturer: PACIFIC LASERTECH, LLC; 215 Bingham Dr # 110; San Marcos CA 92069-1403
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.
• Quantity in Commerce: 32
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.