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Lumbar Extension Machine for Physical Therapy

FDA Recall #Z-0935-2015 — Class II — December 3, 2013

Recall #Z-0935-2015 Date: December 3, 2013 Classification: Class II Status: Terminated

Product Description

Lumbar Extension Machine for Physical Therapy

Reason for Recall

Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

Recalling Firm

MedX Holdings, Inc. — Ocala, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

9

Distribution

Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.

Code Information

Serial Numbers: 01531280, 01531279, 01531278, 01531284, 01531283, 01531282, 01531281, 01531288, 01531287

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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