Recall Z-1538-2013 ยท REA High-Power Laser Light Show Projector
Laserworld Usa Inc
Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
| Date | Sep 19, 2013 (initiated Jul 19, 2012) |
| Status | Terminated |
| Reason | A potential lack of certification, and/or missing laser certification, laser safety warning and administrative labels, and potentially incomplete Performance Feature set and incomplete User Information were discovered. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | CDRH approves the CAP subject to the following conditions: 1. Laserworld shall expand the scope of the CAP to include all projectors distributed between 2008 and 20l2, including, but not limited to, the Proline Series AG, Revolution Series AG, Club Series AG, Club Series, Pure Light Series, and Revolution Series AG, and Laserworld will continue to evaluate whether these additional projector models have similar defects. 2. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office |
| Quantity | Total distribution of more than 500 units between July1, 2008, and June 30, 2012 |
| Distribution | US Distribution including the states of CA, CO, FL, KS and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.