FDA Device recall Z-0571-2013
SpineSix consists of a motorized treatment table that is controlled by an integral computer
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of SpineSix consists of a motorized treatment table that is controlled by an integral computer by Biomotion Medical Systems, citing 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 involvi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0571-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-12 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomotion Medical Systems |
| Distribution | FL, GA, NJ, NY, PA, TN, WI |
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
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.
Identifiers
| code_info | serial numbers: 1001 through 1054 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0571-2013%22
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