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.
What this means for you
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 Pati
- 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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