Z-2264-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- November 20, 2013
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,346 brochures. Quantity not applicable to web site.
Product Description
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Reason for Recall
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
Distribution Pattern
US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
Code Information
All brochures and online literature printed before November 20, 2013.