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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