[Recalled] 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. — Brochures and
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Hyperion Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2264-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 November 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.