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Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging syst
Recalled June 4, 2014 · FDA recall Z-1668-2014 · Siemens Medical Solutions USA
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. · FDA Class II
Units
177 units
Sold at
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.
Description
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.
Product
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →