25-LHP-928, HeNe Laser System, 25 mW
Reported: September 18, 2024 Initiated: March 1, 2024 #Z-2976-2024
Product Description
25-LHP-928, HeNe Laser System, 25 mW
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.
Details
- Recalling Firm
- PACIFIC LASERTECH, LLC
- Units Affected
- 4
- Distribution
- US Nationwide Distribution
- Location
- San Marcos, CA
Frequently Asked Questions
What product was recalled? ▼
25-LHP-928, HeNe Laser System, 25 mW. Recalled by PACIFIC LASERTECH, LLC. Units affected: 4.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-2976-2024.
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