Medical device recalls Moderate risk

MedX Holdings, Inc. recalls Lumbar Extension Machine for Physical Therapy

Recall date
December 3, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0935-2015
FDA classification
Class II
Brand / firm
MedX Holdings, Inc.
Sold / distributed
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lumbar Extension Machine for Physical Therapy

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