Medical Device
Manufacturing
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Z-2111-2025Class II

Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000

Beyond Laser Systems, LLC / initiated 2025-06-30 / Open, Classified / root cause: labeling and UDI

Beyond Laser Systems, LLC began a recall of Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2111-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Beyond Laser Systems, LLC
Product
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Product code
REA High-Power Laser Light Show Projector
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.
Root cause tag
labeling and UDI
FDA root cause
Radiation Control for Health and Safety Act
Action
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.
Quantity in commerce
10
Distribution
US Nationwide Distribution
Product codes and lots
N/A

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2111-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2111-2025Class IIOngoingFDA Mandated
Z-2112-2025Class IIOngoingFDA Mandated
Z-2113-2025Class IIOngoingFDA Mandated