Events

Recall of Device Recall QuantumPulse machine

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

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
    49609
  • Event Risk Class
    Class 2
  • Event Number
    Z-0582-2009
  • Event Initiated Date
    2008-10-01
  • Event Date Posted
    2009-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73919
  • 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
  • Reason
    Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
  • Action
    Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included: 1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such; 2. An updated operation manual/users guide containing no medical conditions or human body claims; and 3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides. Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.

Device

Device Recall QuantumPulse machine
  • Model / Serial
    All serial numbers.
  • Distribution
    Worldwide Distribution.
  • Product Description
    QuantumPulse machine. Vibe Technologies, Greeley, CO. || The device is used to create light wave frequencies to effect cellular activity.
  • Manufacturer
    VIBE Technologies

Manufacturer

VIBE Technologies
  • Manufacturer Address
    VIBE Technologies, 2329 W 10th St, Greeley CO 80634-3527
  • Source
    USFDA