FDA-Device2014-06-04Class II
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Siemens Medical Solutions USA, Inc.
Hazard
Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belarus, Dominican Rep., France, Germany, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Philippines, Poland, Republic of Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Sweden, Switzerland, Turkey, U.A.E., Ukraine, and United Kingdom.
Affected count
177 units
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2014Don't want to check this manually?
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