BioMotion Medical Systems, LLC: Medical Device Recall in 2012 - (Recall #: Z-0571-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 12, 2012

Date Posted: December 26, 2012

Recall Number: Z-0571-2013

Event ID: 63788

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.

Status: Terminated

Product Quantity: 28 units

Code Information:

serial numbers: 1001 through 1054

Distribution Pattern:

Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.

Voluntary or Mandated:

Voluntary: Firm initiated