Newport Laser Units (Unspecified) – Key Control Compliance (2024)
Faulty laser key switch can allow unintended laser operation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
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
Products Sold
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
A medical device manufacturer is recalling Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL due to 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. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026