Laser light show projectors manufactured by BLS, Model PURE 5000/10000
Beyond Laser Systems, LLC began a recall of Laser light show projectors manufactured by BLS, Model PURE 5000/10000 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-2113-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Beyond Laser Systems, LLC
- Product
- Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
- 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
- 3
- Distribution
- US Nationwide Distribution
- Product codes and lots
- N/A
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2111-2025 | Class II | Ongoing | FDA Mandated | ||
| Z-2112-2025 | Class II | Ongoing | FDA Mandated | ||
| Z-2113-2025 | Class II | Ongoing | FDA Mandated |
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