Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Summary
The FDA issued a Class II for Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. by Beyond Laser Systems, LLC. Reason: The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically .
Details
Source
Device Recall
External ID
Z-2112-2025
Action Date
2025-07-23
Status
Ongoing
Category
device
Product Description
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Lot/Code Info: N/A
Quantity Affected: 12
Reason for Recall
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
Distribution
US Nationwide Distribution
Type: FDA Mandated
Recall Initiated: 2025-06-30
Company
Austin, TX
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 109 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beyond Laser Systems, 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 (Beyond Laser Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beyond Laser Systems, LLC have FDA actions?
Beyond Laser Systems, 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-2112-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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