Medical device recalls Moderate risk

Umano Medical, Inc. recalls AC-powered adjustable medical beds with built-in electric DC actuators and controls.

Recall date
April 11, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1135-2022
FDA classification
Class II
Brand / firm
Umano Medical, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.

Why it was recalled

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

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

What was recalled

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

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