PACIFIC LASERTECH, LLC 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-2977-2024
N-LHP-928, HeNe Laser System, 35 mW Recall
Issued September 18, 2024 · PACIFIC LASERTECH, LLC
In September 2024, PACIFIC LASERTECH, LLC recalled the N-LHP-928, HeNe Laser System, 35 mW, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using N-LHP-928, HeNe Laser System, 35 mW right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PACIFIC LASERTECH, LLC to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- PACIFIC LASERTECH, LLC
- Category
- Health
- Recall date
- September 18, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide Distribution
- Recall number
- FDA-Z-2977-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- PACIFIC LASERTECH, LLC has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.