25-LHP-928, HeNe Laser System, 25 mW
Published September 18, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- PACIFIC LASERTECH, LLC
- Distributor
- US Nationwide Distribution
- Lot
- 25-LHP-928
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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