FDA Enforcement
Class II
Terminated
Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.
Recall: Z-1538-2013
·
Reported September 25, 2013
Enforcement
- Recall Number
- Z-1538-2013
- Event ID
- 62624
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Laserworld Usa Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2013
- Initiation Date
- July 19, 2012
- Classification Date
- September 19, 2013
- Termination Date
- June 29, 2018
- Address
- 363 7th Ave, N/A, New York, NY, 10001-3904, United States
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.
Code Info
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
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