FDA-Device2020-07-01Class II
Oscar 2, Model 250 System
Suntech Medical, Inc.
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.
Sold states
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.
Affected count
1,037 units
Manufactured in
507 Airport Blvd Ste 117, N/A, Morrisville, NC, United States
Products
Oscar 2, Model 250 System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2429-2020Don't want to check this manually?
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