Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1538-2013Class II

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

Laserworld USA Inc / initiated 2012-07-19 / Terminated / root cause: labeling and UDI

Laserworld Usa Inc began a recall of Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1538-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Laserworld USA Inc
Product
Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
Product code
REA High-Power Laser Light Show Projector
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.
Root cause tag
labeling and UDI
FDA 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 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
Quantity in commerce
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.
Product codes and lots
All projectors distributed between 2008 and 2012, including, but not limited to, the Proline Series AG, Revolution Series AG, Club Series AG, Clus Series, Pure Light Series, and Revolution Series AG

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1538-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1538-2013Class IITerminatedVoluntary: Firm initiated