FDA-Device2014-07-09Class II
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Siemens Medical Solutions USA, Inc.
Hazard
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
Sold states
Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
Affected count
790 units
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1962-2014Don't want to check this manually?
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