Summary
The FDA issued a Class II for 25-LHP-928, HeNe Laser System, 25 mW by PACIFIC LASERTECH, LLC. Reason: These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser pr.
Details
Source
Device Recall
External ID
Z-2976-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
25-LHP-928, HeNe Laser System, 25 mW
Lot/Code Info: 25-LHP-928
Quantity Affected: 4
Reason for Recall
These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, 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. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2024-03-01
Company
San Marcos, 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 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PACIFIC LASERTECH, LLC has 3 FDA actions in our database, including 3 recalls.
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 (PACIFIC LASERTECH, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PACIFIC LASERTECH, LLC have FDA actions?
PACIFIC LASERTECH, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2976-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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