Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
This recall has been terminated (originally issued September 11, 2014).
- Company
- Life Force Of Tampa, Llc
- Recall Initiated
- June 27, 2014
- Posted
- September 11, 2014
- Terminated
- July 30, 2015
- Recall Number
- Z-2625-2014
- Quantity
- 10
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.
Lot / Code Info
ALL Life Force Chambers
Root Cause
Labeling False and Misleading
Action Taken
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.