Events

Recall of Device Recall SpineSix01/SpineSix02

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioMotion Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0571-2013
  • Event Initiated Date
    2012-11-12
  • Event Date Posted
    2012-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114771
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Exerciser, powered - Product Code BXB
  • 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.
  • 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.

Device

Device Recall SpineSix01/SpineSix02
  • Model / Serial
    serial numbers: 1001 through 1054
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
  • 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.
  • Manufacturer
    BioMotion Medical Systems, LLC

Manufacturer

BioMotion Medical Systems, LLC
  • Manufacturer Address
    BioMotion Medical Systems, LLC, 6619 North Scottsdale Rd., scottsdale AZ 85250
  • Source
    USFDA