PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: June 12, 2024 Initiated: March 27, 2024 #Z-1946-2024

Product 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 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.

Details

Recalling Firm
Newport Corp
Units Affected
19
Distribution
US Nationwide
Location
Ivine, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Newport Corp. Units affected: 19.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-1946-2024.