Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Laserworld

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Laserworld see related information
Date Initiated by Firm July 19, 2012
Date Posted September 19, 2013
Recall Status1 Terminated 3 on June 29, 2018
Recall Number Z-1538-2013
Recall Event ID 62624
Product Classification High-power laser light show projector - Product Code REA
Product Laserworld RGB & Piko Nano RGB Models

All models are laser light show projectors, and will be used as such.
Code Information 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  
Recalling Firm/
Manufacturer		 Laserworld Usa Inc
363 7th Ave
New York NY 10001-3904
For Additional Information Contact Mr. Jeff Cornell
407-432-7217
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-