FDA Recall 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.

Recall: Z-1946-2024 · Initiated March 27, 2024

Recall

Recall Number
Z-1946-2024
Event Number
94748
FEI Number
3011118306
Product Code
RFN
Status
Open, Classified
Root Cause
Radiation Control for Health and Safety Act
Initiated
March 27, 2024
Posted
June 5, 2024
Address
Newport Corp Unknown Street, Ivine, CA, 92606

Description

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.

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.

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.

Distribution

US Nationwide

Quantity

19