Recall Z-1946-2024 ยท RFN Fiber Optic Communication And Data Transfer
Newport Corp
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.
| Date | Jun 5, 2024 (initiated Mar 27, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Newport will contact each affected customer, distributor and end user, to determine the status of the laser s current hardware and whether the power supply must be replaced. If the power supply has the incorrect hardware and must be replaced, Newport will remedy the defect by replacing the unit with a compliant unit. |
| Quantity | 19 |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.