FDA-Device2014-06-04Class II
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Siemens Medical Solutions USA, Inc.
Hazard
Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler or continuous wave Doppler waveform.
Sold states
Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, KS, LS, MD, MI, MN, MO, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA and WI., and the countries of Australia, Austria, Dominican Rep, France, Germany, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed, Saudi Arabia, Sweden, Switzerland, Turkey, U.A.E. and United Kingdom.
Affected count
257 units
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2014Don't want to check this manually?
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