BioMotion SpineSix Medical Device Field Correction for Regulatory Deficiencies
BioMotion Medical Systems is issuing a field correction for SpineSix treatment tables to address regulatory deficiencies and prepare for premarket clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but is driven by regulatory deficiencies and premarket clearance preparation rather than reported injuries or high-risk pathogens, fitting the criteria for a moderate severity voluntary or administrative action.
Plain-English summary
BioMotion Medical Systems, LLC is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02) to rectify regulatory deficiencies involving the former owners of the product. The company is concurrently preparing the submission of a 510(k) application to receive premarket clearance for the SpineSix.
The SpineSix is a motorized treatment table controlled by an integral computer, intended to reproduce normal spine mechanics and physiological movements. The affected units have serial numbers 1001 through 1054, with a total of 28 units involved in this action.
The devices were distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin. This action is classified as a Class II recall by the FDA.
The recalled product
- 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…
- Manufacturer
- BioMotion Medical Systems, LLC
- Category
- Medical Device — Treatment Table
- Hazard
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- serial numbers: 1001 through 1054
Distribution
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