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
Summary
The FDA issued a Class II for Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LP by Newport Corp. 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. .
Details
Source
Device Recall
External ID
Z-1946-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 19
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.
Distribution
US Nationwide
Type: FDA Mandated
Recall Initiated: 2024-03-27
Company
Ivine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Newport Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Newport Corp have FDA actions?
This is the only FDA action we have on record for Newport Corp in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1946-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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