BEUDAMED
    FDA Recall Terminated

    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.

    Recall: Z-1538-2013 · Initiated July 19, 2012

    Recall

    Recall Number
    Z-1538-2013
    Event Number
    62624
    Firm
    Laserworld Usa Inc
    FEI Number
    3010536806
    Product Code
    REA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 19, 2012
    Posted
    September 19, 2013
    Terminated
    June 29, 2018
    Address
    363 7th Ave, New York, NY, 10001-3904

    Description

    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.

    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.

    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 and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 3. Laserworld will maintain records to document the number of projectors returned under the CAP, and will document the specific items of non-compliance addressed for each product tested, repaired, relabeled and/or replaced. 4. Laserworld will provide CDRH with quarterly status updates on the progress of the CAP. 5. The correction of the non-compliant products must be made at no cost to the customers. You may proceed with implementation of the CAP (subject to the conditions

    Distribution

    US Distribution including the states of CA, CO, FL, KS and PA.

    Quantity

    Total distribution of more than 500 units between July1, 2008, and June 30, 2012