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Open, Classified

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.

FDA Recall Z-1946-2024 · Posted 2024-06-05

Recalling FirmNewport Corp
Recall StatusOpen, Classified
Product CodeRFN
Date Initiated2024-03-27
Product Quantity19

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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