Medical device recalls Moderate risk

American National Mfg Inc recalls Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air fl…

Recall date
July 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2605-2016
FDA classification
Class II
Brand / firm
American National Mfg Inc
Sold / distributed
Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.

Why it was recalled

The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.

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

What was recalled

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

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