FDA-Device2016-05-11Class II
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Siemens Medical Solutions USA, Inc.
Hazard
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
Sold states
Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
Affected count
87
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2016Don't want to check this manually?
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