Austin, TX, United States
Beyond Laser Systems, LLC recalls
1 recall recorded since 2018, most recently on 30 June 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 June 2025
- 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 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
- Initiated
- FDA Mandated
- Recall numbers
- Z-2112-2025, Z-2111-2025, Z-2113-2025
- Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
- Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
- Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.