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U.S. Department of Health and Human Services

Class 2 Device Recall Life Force Chamber

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  Class 2 Device Recall Life Force Chamber see related information
Date Initiated by Firm June 27, 2014
Date Posted September 11, 2014
Recall Status1 Terminated 3 on July 30, 2015
Recall Number Z-2625-2014
Recall Event ID 69043
Product Classification Chamber, patient isolation - Product Code LGM
Product Life Force Chamber

Product Usage:The product is intended for restful contemplation and spirituality.
Code Information ALL Life Force Chambers
Recalling Firm/
Manufacturer		 Life Force of Tampa, LLC
4125 Gunn Hwy Ste B1
Tampa FL 33618-8788
For Additional Information Contact Douglas G. Cornell
813-961-4655
Manufacturer 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
FDA Determined
Cause 2		 Labeling False and Misleading
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.
Quantity in Commerce 10
Distribution Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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