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Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5M
Recalled May 11, 2016 · FDA recall Z-1592-2016 · Siemens Medical Solutions USA
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. · FDA Class II
Units
87
Sold at
Worldwide distribution. US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.
Description
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.
Product
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →