Life Force Chamber
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2625-2014 | Class II | Terminated | Voluntary: Firm initiated |
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