Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0571-2013 — 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 setting

U.S. FDA — Device Enforcement · United States · 2012-11-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0571-2013
Date of alert: 2012-11-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BioMotion Medical Systems, LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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