Recall Z-0571-2013— BioMotion Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by BioMotion Medical Systems, LLC, initiated 2012-11-12, terminated 2013-11-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- BioMotion Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-12
- Terminated
- 2013-11-05
- Firm location
- scottsdale, AZ, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.