Z-0571-2013Class II

SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is...

Name: Z-0571-2013 SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is...
Creator: BioMotion Medical Systems, LLC
Published: 2012-11-12
License: https://open.fda.gov/license/

BioMotion Medical Systems, LLC / initiated 2012-11-12 / Terminated

FDA source

BioMotion Medical Systems, LLC began a recall of 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... on 2012-11-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0571-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-12
Posted: 2012-12-20
Terminated: 2013-11-05
Recalling firm: BioMotion Medical Systems, LLC
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.
Product code: BXB Exerciser, Powered
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.
FDA 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 in commerce: 28 units
Distribution: Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
Product codes and lots: serial numbers: 1001 through 1054

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code BXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)