Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2625-2014Class II

Life Force Chamber

Life Force of Tampa, LLC / initiated 2014-06-27 / Terminated / root cause: labeling and UDI

Life Force of Tampa, LLC began a recall of Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2625-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Life Force of Tampa, LLC
Product
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Product code
LGM Chamber, Patient Isolation
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
Root cause tag
labeling and UDI
FDA root cause
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.
Product codes and lots
ALL Life Force Chambers

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2625-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2625-2014Class IITerminatedVoluntary: Firm initiated