Newport Corp Recall 94748
Description: Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
Newport Corp Recall 94748 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1946-2024 |
| Event ID | 94748 |
| Event Description | Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone. |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 19 |
| Recall Reason | According to 21 CFR 1040.10(f)(4), 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. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern. |
| Device Classification | 20240612 |
| Device Code Info | P/N N-LHP-928 Set S/N (laser head + power supply): 6905AE, 6907AE, 9023AE, 3148AF, 6899AE 6909AE, 9025AE, 5695AF, 5696AF, 5691AF, 5692AF, 5693AF, 5694AF (9 of them in Irvine warehouse) P/N: N6-LPL-944-080 Power supply S/N: 23060081, 23060079 |
| Center Classification Date | 20240605 |
| Recall Initiation Date | 20240327 |
| Recalling Firm | Newport Corp |
| Initial Notification | Letter |
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