Recalls for Equipment, Traction, Powered

This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.

Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs

Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs

On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification in the intended use of the device.

The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.