PACIFIC LASERTECH, LLC Recall 95290
Description: N-LHP-928, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC Recall 95290 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2977-2024 |
| Event ID | 95290 |
| Event Description | N-LHP-928, HeNe Laser System, 35 mW |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 32 |
| Recall 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. |
| Device Classification | 20240918 |
| Device Code Info | N-LHP-928 |
| Center Classification Date | 20240910 |
| Recall Initiation Date | 20240301 |
| Recalling Firm | PACIFIC LASERTECH, LLC |
| Initial Notification | Letter |
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