CLASS II ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report
Laser light show projectors recalled by Beyond Laser Systems
Beyond Laser Systems is recalling Laser light show projectors, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2111-2025
- FDA event ID
- 97176
- Recalling firm
- Beyond Laser Systems, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2025
- FDA classified
- 16 Jul 2025
- Reported
- 23 Jul 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2025 | Recall initiated by company | |
| 16 Jul 2025 | Classified by FDA | +16 days |
| 23 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Laser light show projectors recalled?
Yes. Beyond Laser Systems recalled Laser light show projectors on 30 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2111-2025.
Why was it recalled?
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.
Which lots are affected?
N/A
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beyond Laser Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Laser light show projectors recalled by Beyond Laser Systems | Beyond Laser Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Laser light show projectors recalled by Beyond Laser Systems | Beyond Laser Systems | Device Malfunction | Nationwide |
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