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Terminated

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

FDA Recall Z-1538-2013 · Posted 2013-09-19

Recalling FirmLaserworld Usa Inc
Recall StatusTerminated
Product CodeREA
Date Initiated2012-07-19
Date Terminated2018-06-29
Product QuantityTotal distribution of more than 500 units between July1, 2008, and June 30, 2012

Reason for Recall

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.

Firm 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

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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