Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2012
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 safel
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 involvi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioMotion Medical Systems, LLC recalled SpineSix consists of a motorized treatment table that is controlled by an integral comput… - a moderate-severity action.
SpineSix consists of a motorized treatment table that is controlled by an integral comput… was recalled by BioMotion Medical Systems, LLC in December 26, 2012. Reason: BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial num…. Check the official notice for the remedy. Verify recall #Z-0571-2013 with the FDA Devices before acting.
The recall
BioMotion Medical Systems, LLC issued this moderate-severity FDA Devices recall-BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial num….
- Moderate
- severity level
- 28 units
- affected scope
- Class II
- classification
- December 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0571-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0571-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on November 12, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. BioMotion Medical Systems, LLC is listed as the recalling firm, operating out of scottsdale, AZ. Federal records list the affected scope as 28 units.
The documented reason for this recall is: 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 pro… Distribution data in the federal record shows the product reached: Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
28 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0571-2013 |
| Date reported | December 26, 2012 |
| Date initiated | November 12, 2012 |
| Recalling firm | BioMotion Medical Systems, LLC |
| Firm location | scottsdale, AZ |
| Affected scope | 28 units |
| Distribution | Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0571-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioMotion Medical Systems, LLC. Units affected: 28 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0571-2013.
Where was the recalled product distributed? ▼
Distribution: Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0571-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.