Medical device recalls Moderate risk

Suntech Medical, Inc. recalls Oscar 2, Model 250 System

Recall date
April 20, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2429-2020
FDA classification
Class II
Brand / firm
Suntech Medical, Inc.
Sold / distributed
Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saud…

Why it was recalled

The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.

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

What was recalled

Oscar 2, Model 250 System

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