Reported Dec 26, 2012 · Terminated
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by…
BioMotion Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMotion Medical Systems, LLC · 6619 North Scottsdale Rd. · scottsdale, AZ · 85250
Is this the product you have?
- 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.
- Lot codes and dates
- serial numbers1001 through 1054
- Amount recalled
- 28 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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