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U.S. Department of Health and Human Services

Class 2 Device Recall Beyond Laser Systems, LLC.

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 Class 2 Device Recall Beyond Laser Systems, LLC.see related information
Date Initiated by FirmJune 30, 2025
Date PostedJuly 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2111-2025
Recall Event ID 97176
Product Classification High-power laser light show projector - Product Code REA
ProductLaser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Code Information N/A
FEI Number 3021802180
Recalling Firm/
Manufacturer		 Beyond Laser Systems, LLC
4211 Todd Ln Ste A
Austin TX 78744-1083
For Additional Information Contact
512-220-9339 Ext. 302
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionBeyond 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.
Quantity in Commerce10
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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