BEUDAMED
    FDA Recall Terminated

    Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.

    Recall: Z-2625-2014 · Initiated June 27, 2014

    Recall

    Recall Number
    Z-2625-2014
    Event Number
    69043
    Firm
    Life Force of Tampa, LLC
    FEI Number
    3010406411
    Product Code
    LGM
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    June 27, 2014
    Posted
    September 11, 2014
    Terminated
    July 30, 2015
    Address
    4125 Gunn Hwy, Ste B1, Tampa, FL, 33618-8788

    Description

    Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.

    Reason

    The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat

    Action

    Life Force of Tampa LLC sent an URGENT: MEDICAL DEVICE RECALL letter dated June 27, 2014 to all affected customers. The letter instructed the customers to: 1) Immediately remove and discard all copies of the labeling material. 2) Remove all electronic copies of the materials from any publicly accessible locations (e.g. website). 3) Complete and return the Acknowledgment form to Life Force of Tampa. For questions or concerns contact Douglas G. Cornell at (813) 961-4655.

    Distribution

    Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.

    Quantity

    10