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Suntech Medical, Inc. recalls Oscar 2, Model 250 System
Recalled July 1, 2020 · FDA recall Z-2429-2020 · Suntech Medical
Hazard
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. · FDA Class II
Units
1,037 units
Sold at
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, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, Vietnam.
Description
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.
Product
Oscar 2, Model 250 System
Manufacturer(s)
Suntech Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →