SpineSix consists of a motorized treatment table that is controlled… — Class II medical device recall Z-0571-2013
Terminated recall by BioMotion Medical Systems, LLC, reported 2012-12-26, distributed in FL, GA, NJ, NY, PA, TN, WI. BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numb
| Recall number | Z-0571-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMotion Medical Systems, LLC, scottsdale, AZ, United States |
| Recall initiated | 2012-11-12 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-11-05 |
| Distributed | FL, GA, NJ, NY, PA, TN, WI |
| Quantity | 28 units |
| Serial numbers | 1001 |
Product
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 reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.