FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1946-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-03-27
- Posted
- 2024-06-05
- Terminated
- not on file
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFN
- Firm FEI
- 3011118306
- Firm city
- Ivine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28