Events

Recall of Device Recall HyperBlue 1530, multiuse diode laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hyperion Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67814
  • Event Risk Class
    Class 2
  • Event Number
    Z-2264-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2014-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126389
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lasers for temporary increase of clear nail in patients with onychomycosis - Product Code PDZ
  • Reason
    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.
  • Action
    Hyperion Medical notified all sales representatives by private courier letter to stop distributing the the sales brochure and return or destroy existing stocks of the brochure. Sales representatives were instructed not to demonstrate the 15 mm hand piece with the HyberBlue 1530 and to remove from any of their individual internet web sites any information about multiple wavelength use or the 15 mm handpiece accessory. The letter to the sales representatives included delivery confirmation. The information on the firm's web site for this product regarding multiple wavelengths and the 15 mm handpiece was removed. For further information please call (214) 914-3133.

Device

Device Recall HyperBlue 1530, multiuse diode laser
  • Model / Serial
    All brochures and online literature printed before November 20, 2013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
  • 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.
  • Manufacturer
    Hyperion Medical

Manufacturer

Hyperion Medical