FDAFDA · Food and drugs·Recall number Z-2264-2014
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.
Published August 27, 2014 · Recall initiated: November 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hyperion Medical
- Distributor
- US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
- Lot
- All brochures and online literature printed before November 20, 2013.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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