Reported Aug 27, 2014 · Terminated
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and…
Hyperion Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hyperion Medical · 15914 Midway Rd · Addison, TX · 75001-4261
Is this the product you have?
- 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.
- Lot codes and dates
- All brochures and online literature printed before November 20, 2013.
- Amount recalled
- 3,346 brochures. Quantity not applicable to web site.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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