San Marcos, CA, United States
PACIFIC LASERTECH, LLC recalls
1 recall recorded since 2018, most recently on 1 March 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-2976-2024, Z-2977-2024, Z-2975-2024
- 25-LHP-928, HeNe Laser System, 25 mW
- N-LHP-928, HeNe Laser System, 35 mW
- 25-LHP-828, HeNe Laser System, 35 mW
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.