FDA Medical Device Recalls (openFDA)
PACIFIC LASERTECH, LLC: 25-LHP-928, HeNe Laser System, 25 mW
- Recall number
- Z-2976-2024
- Recalling firm
- PACIFIC LASERTECH, LLC
- Product
- 25-LHP-928, HeNe Laser System, 25 mW
- Status
- Open, Classified
- Initiated
- 2024-03-01
- Posted
- 2024-09-10
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 4
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 25-LHP-928
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RDW
- Firm FEI
- 3015195092
- Firm city
- San Marcos
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28