FDA Medical Device Recalls (openFDA)
Laserworld Usa Inc: Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
- Recall number
- Z-1538-2013
- 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.
- Status
- Terminated
- Initiated
- 2012-07-19
- Posted
- 2013-09-19
- Terminated
- 2018-06-29
- 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 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REA
- Firm FEI
- 3010536806
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28