Recall Z-2625-2014 ยท LGM Chamber, Patient Isolation
Life Force of Tampa, LLC
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
| Date | Sep 11, 2014 (initiated Jun 27, 2014) |
| Status | Terminated |
| 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 |
| 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 | 10 |
| Distribution | Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.