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Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Recalled June 4, 2014 · FDA recall Z-1667-2014 · Siemens Medical Solutions USA
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. · FDA Class II
Units
257 units
Sold at
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.
Description
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.
Product
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →