Z-1946-2024Class II

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...

Name: Z-1946-2024 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...
Creator: Newport Corp
Published: 2024-03-27
License: https://open.fda.gov/license/

Newport Corp / initiated 2024-03-27 / Open, Classified

FDA source

Newport Corp began a recall of 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 on 2024-03-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1946-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-27
Posted: 2024-06-05
Recalling firm: Newport Corp
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.
Product code: RFN Fiber Optic Communication And Data Transfer
Reason for recall: 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.
FDA 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 in commerce: 19
Distribution: US Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2024	Class II	Ongoing	FDA Mandated	2024-06-12	2024-06-05

Product code RFN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)