Recall Z-0571-2013 ยท BXB Exerciser, Powered
BioMotion Medical Systems, LLC
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduc
| Date | Dec 20, 2012 (initiated Nov 12, 2012) |
| Status | Terminated |
| Reason | BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. |
| Root cause | No Marketing Application |
| Action | BioMotion issued a field correction letter dated October 18, 2012 for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to all affected customers. The letter identified the product, problem, and actions to be taken. BioMotion is preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. Contact the firm at 772-405-7899 for questions concerning this letter. |
| Quantity | 28 units |
| Distribution | Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.