Beyond Laser Systems, LLC recalls Laser light show projectors manufactured by BLS
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.
Affected product
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
What the firm is doing
Beyond Laser Systems (BLS) mail the CAP letters to all affected customers. BLS will complete the procedure and ship the laser projector back to the customer within 14-21 days of receiving the units in our facility. BLS will provide a UPS shipping label to the customer for shipping to our facility and cover the expense of shipping the units back to the customer via UPS. If you have any questions, call 512-220-9339 ext 302.
DistributionShow detailsHide
US Nationwide Distribution
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2112-2025
- FDA device classification · REAOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Beyond Laser Systems, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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